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Condition 條件

Fistula in Ano and Anorectal Abscess
Ano 和肛門直腸膿腫中的瘺管

Editors: Assar A. Rather MD, FACS, FASCRS; Esther Jolanda van Zuuren MD; Zbigniew Fedorowicz PhD, MSc, DPH, BDS, LDSRCS; Katharine DeGeorge MD, MS
編輯：Assar A. Rather 醫學博士、FACS、FASCRS;Esther Jolanda van Zuuren 醫學博士;Zbigniew Fedorowicz 博士、理學碩士、DPH、BDS、LDSRCS;Katharine DeGeorge MD， MS

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Management 管理

Management Overview 管理概述

for treatment of acute anorectal abscess
用於治療急性肛門直腸膿腫
- timely surgical drainage is the primary treatment of acute anorectal abscess (ASCRS Grade 1C; SICCR 1B; German S3 Strong clinical consensus)
  及時手術引流是急性肛門直腸膿腫（ASCRS 1C 級 ;SICCR 1B; 德國 S3 Strong 臨床共識）
- adjunctive antibiotics are not typically indicated for prevention of fistula formation in patients with uncomplicated anorectal abscess who have undergone drainage; however, there is some evidence that adjunctive antibiotics for 5-10 days (ciprofloxacin 500 mg orally every 12 hours plus metronidazole 500 mg orally every 8 hours for 7 days) may decrease the rate of subsequent fistula formation, even in young, immunocompetent adults
  輔助抗生素通常不用於預防無併發症肛門直腸膿腫患者經引流后形成瘺管;然而，有一些證據表明，輔助抗生素 5-10 天（環丙沙星 500 mg，口服，每 12 小時一次，加甲硝唑 500 mg，口服，每 8 小時一次，持續 7 天）可能會降低隨後瘺管形成的速度，即使在免疫功能正常的年輕成人中也是如此
- consider adjunctive antibiotics in select patients, such as patients with cellulitis, underlying immunosuppression, or systemic signs of infection
  對於特定患者，例如蜂窩織炎、潛在免疫抑制或全身感染體征的患者，考慮使用輔助抗生素
- in patients with anorectal abscess plus fistula, consider concomitant fistulotomy with incision and drainage (ASCRS Grade 2B)
  對於肛門直腸膿腫加瘺管的患者，考慮同時進行瘺管切開術和切開引流術（ASCRS 2B 級）
for treatment of fistula in ano^2
,4
用於治療 ANO^2,4 中的瘺管
- first, eliminate infection with abscess drainage, as fistula will not heal in presence of infection and some fistulas may heal spontaneously after adequate drainage of infection
  首先，通過膿腫引流消除感染，因為瘺管在感染的情況下不會癒合，並且一些瘺管可能會在感染充分引流后自發癒合
- establish adequate nutritional status so healing optimized
  建立足夠的營養狀況，優化癒合
- clarify location and complexity of fistula, including internal opening and course of all tracts, so potential secondary tracts are not missed
  闡明瘺管的位置和複雜性，包括所有束的內部開口和走行，這樣就不會錯過潛在的繼發性束
for treatment of simple fistula in ano in patients with normal anal sphincter function
用於治療肛門括約肌功能正常的 ANO 單純性瘺管
- consider fistulotomy as initial option (ASCRS Grade 1B; German S3 Grade B, Level 2b)
  考慮將瘺管切開術作為初始選擇（ASCRS 1B 級 ; 德語 S3 B 級，2b 級）
- marsupialization may improve wound healing (SICCR 1B)
  造袋術可改善傷口癒合（SICCR 1B）
- alternative treatment options include
  替代治療方案包括
  - ligation of intersphincteric fistula tract (LIFT) (ASCRS Grade 1B; SICCR 1B; German S3 Grade A, Level 1b)
    括約肌間瘺束結紮術（LIFT）（ASCRS 1B 級 ;SICCR 1B; 德語 S3 A 級，1b 級）
  - fibrin glue (ASCRS Grade 2B; German S3 Grade B, Level 1b)
    纖維蛋白膠（ASCRS 2B 級 ; 德語 S3 B 級，1b 級）
for treatment of complex fistula in ano
用於治療 ANO 中的複雜瘺管
- the goal of management is to eliminate the internal opening of the fistula and any associated epithelialized tracks while maintaining anal sphincter function
  治療的目標是消除瘺管的內部開口和任何相關的上皮化軌道，同時保持肛門括約肌功能
- sphincter-sparing procedures are preferred for closure of complex anal fistulas (German S3 Grade A, Level 1a)
  保留括約肌的手術是閉合複雜肛瘺的首選（德國 S3 A 級，1a 級）
- options of sphincter-sparing procedures include any of the following
  保留括約肌手術的選擇包括以下任何一種
  - endoanal, endorectal, or mucosal advancement flaps (ASCRS Grade 1B; SICCR 1B)
    肛門內、直腸內或粘膜前移皮瓣（ASCRS 1B 級 ;SICCR 1B）
  - ligation of intersphincteric fistula tract (LIFT) (ASCRS Grade 1B; SICCR 1B; German S3 Grade A, Level 1b)
    括約肌間瘺束結紮術（LIFT）（ASCRS 1B 級 ;SICCR 1B; 德語 S3 A 級，1b 級）
  - fistula excision with direct sphincter reconstruction (German S3 Grade A, Level 1b)
    瘺管切除術聯合直接括約肌重建（德國 S3 A 級，1b 級）
  - biomaterial injections, such as either of following
    生物材料注射，例如以下任一
    - fibrin glue injection (ASCRS Grade 2B; SICCR 2B; German S3 Grade B, Level 1b)
      纖維蛋白膠注射（ASCRS 2B 級 ;SICCR 2B; 德語 S3 B 級，1b 級）
    - anal fistula plug (ASCRS Grade 2B; SICCR 1C), including
      肛瘺栓（ASCRS 2B 級 ;SICCR 1C），包括
      - Surgisis anal fistula plug (German S3 Grade B, Level 1b)
        手術肛瘺栓（德國 S3 B 級，1b 級）
      - Gore Bio-A fistula plug (German S3 Grade C, Level 4)
        Gore Bio-A 瘺管栓（德國 S3 C 級，4 級）
  - biomaterial interventions may be associated with lower healing rates but also lower incontinence rates (German S3 Grade A, Level 1b)
    生物材料干預可能與較低的癒合率有關，但也與較低的失禁率有關（德國 S3 A 級，1b 級）
- sphincter-sacrificing procedures, such as cutting setons, are generally not recommended for complex fistulas or only recommended with caution
  通常不建議對複雜瘺管使用犧牲括約肌的手術，例如切割掛線，或者僅在謹慎使用時推薦使用
- newer techniques with limited or inconsistent evidence of efficacy include
  療效證據有限或不一致的新技術包括
- limited evidence available to compare efficacy of different procedures for closure of high perianal fistulas
  可用於比較不同手術閉合高位肛周瘺的效果的證據有限
  - LIFT and advancement flaps may have similar healing and recurrence rates, but LIFT generally a simpler procedure to perform
    LIFT 和推進皮瓣可能具有相似的癒合率和復發率，但 LIFT 通常是一種更簡單的手術
  - anal fistula plug and mucosal advancement flap associated with similar functional outcome, quality of life, and recurrence rates in patients with high transsphincteric perianal fistula
    經括約肌肛周瘺患者的肛瘺栓和粘膜前移皮瓣與相似的功能結局、生活品質和復發率相關
  - fibrin glue injection appears less effective than seton therapy for healing medium or high anal fistulas, but may have lower rate of incontinence
    纖維蛋白膠注射在治癒中度或高度肛瘺方面似乎不如 Seton 療法有效，但失禁的發生率可能較低
- defunctioning of the bowel via colostomy diversion may be needed for severe, nonhealing anal fistula
  對於嚴重的、不癒合的肛瘺，可能需要通過結腸造口改道術使腸道功能失能
management of Crohn disease-associated fistula
克羅恩病相關瘺管的治療
- medication is primary treatment for anorectal fistulas in patients with Crohn disease
  藥物治療是克羅恩病患者肛門直腸瘺的主要治療方法
- surgery typically reserved for infection control and occasionally as an adjunct for cure
  手術通常用於控制感染，偶爾作為治癒的輔助手段
  - avoid surgery if fistulas are asymptomatic (ASCRS Grade 1C)
    如果瘺管無癥狀（ASCRS 1C 級），請避免手術
  - consider fistulotomy for symptomatic, simple, low anal fistulas (ASCRS Grade 1C)
    對於有癥狀的、簡單的、低位的肛瘺（ASCRS 1C 級），考慮進行瘺管切開術
  - consider loose setons for multimodal therapy of fistulizing anorectal Crohn disease and for long-term disease control (ASCRS Grade 1C)
    考慮使用鬆散的 seton 進行瘺管性肛門直腸克羅恩病的多模式治療和長期疾病控制（ASCRS 1C 級）
  - consider permanent diversion or proctectomy for uncontrollable symptoms from complex Crohn fistula (ASCRS Grade 1C)
    對於複雜克羅恩瘺（ASCRS 1C 級）無法控制的癥狀，考慮永久性改道術或直腸切除術
  - if surgical closure needed, consider endoanal advancement flap, anal fistula plug, and LIFT for Crohn fistula in ano (ASCRS Grade 2B)
    如果需要手術閉合，考慮肛門內前移皮瓣、肛瘺栓和 LIFT 治療肛門瘺（ASCRS 2B 級）
for anorectal fistula associated with tuberculosis, anti-tuberculosis drugs are first-line treatment²
對於與結核病相關的肛門直腸瘺，抗結核藥物是一線治療 ²

Antibiotics for Anorectal Abscess
肛門直腸膿腫的抗生素

CLINICIANS' PRACTICE POINT
臨床醫生執業要點

While antibiotics are not routinely recommended for the prevention of fistula formation in otherwise healthy, immunocompetent patients after drainage of an anorectal abscess, a systematic review which excluded studies of immunocompromised patients found reduced rates of fistula formation in patients treated with metronidazole 500 mg orally every 8 hours plus ciprofloxacin 500 mg orally every 12 hours for 7 days. This suggests that this regimen of adjunctive antibiotics may be reasonable not only for patients at higher risk of infection or fistula formation (such as those with immunosuppression, signs of systemic disease, severe cellulitis, or recurrent infection), but for patients with uncomplicated anorectal abscess as well. However, adjunctive antibiotics are not currently recommended by professional organizations for uncomplicated anorectal abscess.
雖然不常規推薦使用抗生素來預防肛門直腸膿腫引流后其他方面健康、免疫功能正常的患者形成瘺管，但一項排除免疫功能低下患者研究的系統評價發現，甲硝唑 500 mg 口服每 8 小時一次加環丙沙星 500 mg 口服每 12 小時一次，持續 7 天的患者瘺管形成率降低。這表明這種輔助抗生素方案可能不僅適用於感染或瘺管形成風險較高的患者（例如免疫抑制、全身性疾病體征、嚴重蜂窩織炎或復發性感染的患者），而且也適用於無併發症的肛門直腸膿腫患者。然而，專業組織目前不推薦將輔助抗生素用於無併發症的肛門直腸膿腫。

ASCRS suggestions on the use of antibiotics for anorectal abscess
ASCRS 關於使用抗生素治療肛門直腸膿腫的建議
- for treatment of uncomplicated anorectal abscess, adjuvant antibiotics after incision and drainage are not typically necessary (ASCRS Weak recommendation, Moderate-quality evidence)
  對於單純性肛門直腸膿腫的治療，切開引流后通常不需要輔助抗生素治療（ASCRS 弱推薦，中等質量證據）
- consider adjuvant antibiotics in patients with significant cellulitis, underlying immunosuppression, or systemic signs of infection (ASCRS Weak recommendation, Moderate-quality evidence)
  對於有嚴重蜂窩織炎、潛在免疫抑制或全身感染體征的患者，考慮使用輔助抗生素（ASCRS 弱推薦，中等質量證據）
- Reference - ASCRS clinical practice guideline on management of anorectal abscess, fistula-in-ano, and rectovaginal fistula (Dis Colon Rectum 2022 Aug 1;65(8):964), commentary can be found in Dis Colon Rectum 2023 Apr 1;66(4):e174
  參考資料 - ASCRS 肛門直腸膿腫、肛瘺和直腸陰道瘺管理臨床實踐指南（Dis Colon Rectum 2022 年 8 月 1 日;65（8）：964），評論可在 Dis Colon Rectum 2023 年 4 月 1 日找到;66（4）：e174
WSES/ASST suggestions on the use of antibiotics for anorectal abscess
WSES/ASST 關於使用抗生素治療肛門直腸膿腫的建議
- consider adjuvant antibiotics for patients with anorectal abscess that has been drained who have sepsis and/or infection of surrounding soft tissue or with impaired immune response (WSES/AAST Weak recommendation, Low-quality evidence)
  對於已引流的肛門直腸膿腫患者、膿毒症和/或周圍軟組織感染或免疫反應受損的患者，考慮使用輔助抗生素（WSES/AAST 弱推薦，低質量證據）
- consider sampling of drained purulent material in patients with risk factors for multidrug-resistant organism infection, recurrent infections, nonhealing wounds, and high risk patients such as patients with HIV or impaired immune function (WSES/AAST Weak recommendation, Very low-quality evidence)
  對於具有多重耐葯微生物感染、復發性感染、不癒合傷口危險因素的患者以及 HIV 感染者或免疫功能受損等高危患者，考慮對引流的膿性物質進行採樣（WSES/AAST 弱推薦，極低質量證據）
- Reference - WSES/AAST guideline on anorectal emergencies (World J Emerg Surg 2021 Sep 16;16(1):48)
  參考資料 - WSES/AAST 肛門直腸急症指南（World J Emerg Surg 2021,9 月 16 日;16（1）：48）
if using antibiotics after incision and drainage for uncomplicated abscess, consider ciprofloxacin 500 mg orally every 12 hours plus metronidazole 500 mg orally every 8 hours for 7 days (Surgery 2017 Nov;162(5):1017)
如果因無併發症的膿腫切開引流後使用抗生素，請考慮環丙沙星 500 mg 口服，每 12 小時一次，加甲硝唑 500 mg 口服，每 8 小時一次，持續 7 天（外科 2017 年 11 月;162（5）：1017）

Evidence Synopsis 證據概要

A recent systematic review demonstrated that antibiotics for 5-10 days following abscess incision and drainage decreased the rate of subsequent fistula formation in patients with immunocompetence, suggesting that pre-emptive adjuvant antibiotics in patients with uncomplicated abscess after drainage may be useful. However, 1 of the 2 randomized trials included in the systematic review showed that amoxicillin-clavulanate for 10 days did not improve abscess healing and actually increased the fistula rate. In contrast, the other included randomized trial showed that metronidazole plus ciprofloxacin for 7 days decreased the fistula rate. Due to this heterogeneity, the systematic review should be interpreted with caution and the knowledge that ciprofloxacin plus metronidazole may be of benefit, while amoxicillin-clavulanate appeared to increase fistula development.
最近的一項系統評價表明，膿腫切開引流后 5-10 天的抗生素可降低免疫功能正常患者後續瘺管形成的速度，這表明對引流后無併發症膿腫患者進行搶先輔助抗生素治療可能有用。然而，系統評價中包括的 2 項隨機試驗中有 1 項表明，阿莫西林克拉維酸 10 天並沒有改善膿腫癒合，實際上增加了瘺管發生率。相比之下，另一項納入的隨機試驗顯示，甲硝唑加環丙沙星 7 天可降低瘺管發生率。由於這種異質性，應謹慎解釋系統評價，並瞭解環丙沙星加甲硝唑可能有益，而阿莫西林克拉維酸似乎會增加瘺管的發生。

STUDY SUMMARY 研究總結
antibiotics for 5-10 days may reduce fistula rate after incision and drainage of anorectal abscess in adults without immunosuppression
對於無免疫抑制的成人，抗生素 5-10 天可降低肛門直腸膿腫切開引流后的瘺管率
SYSTEMATIC REVIEW: Am J Surg 2019 May;217(5):910
系統評價： Am J Surg 2019 年 5 月;217(5):910
based on systematic review limited by heterogeneity

systematic review of 6 studies (2 randomized trials, 1 prospective cohort and 3 retrospective cohort studies) comparing antibiotics vs. no antibiotics for 5-10 days in 817 adults (mean age 37 years, 79.6% male) who had incision and drainage for anorectal abscess and were followed for 1-30 months

exclusion criteria included immunocompromised patients and patients with primary inflammatory bowel disease, neoplasm, radiation exposure, or horseshoe abscesses

antibiotic regimens varied by study protocol in 4 studies, or were ciprofloxacin-metronidazole 500 mg orally every 12 hours-500 mg every 8 hours for 7 days in 1 trial, and amoxicillin-clavulanate 875 mg-125 mg orally twice daily for 10 days in 1 trial

fistulas were identified in follow-up by anoscopy, visual identification of a perianal tract, or palpable communicating tract on digital rectal exam

comparing antibiotics to no antibiotics, fistula occurred in 16% vs. 24% (odds ratio 0.64, 95% CI 0.43-0.96) in analysis of 3 studies with 514 patients, results limited by significant heterogeneity

Reference - Am J Surg 2019 May;217(5):910
STUDY SUMMARY 研究總結
metronidazole plus ciprofloxacin for 7 days may decrease postoperative fistula rate by about 16% after incision and drainage of perianal abscess in adults without immunosuppression
對於無免疫抑制的成人，甲硝唑加環丙沙星 7 天可能會使肛周膿腫切開引流後術后瘺管發生率降低約 16%
RANDOMIZED TRIAL: Surgery 2017 Nov;162(5):1017
隨機試驗：外科 2017 年 11 月;162(5):1017
based on quasi-randomized trial

307 adults (mean age 41 years, 73% male) were randomized to receive metronidazole 500 mg orally every 8 hours plus ciprofloxacin 500 mg orally every 12 hours for 7 days in addition to standard care vs. standard care only and followed for 3 months

exclusion criteria included patients with immunocompromise, previous operation in anal area, coexisting fistula, inflammatory bowel disease, anal cancer or trauma, history of pelvic area radiation, cellulitis, horseshoe abscess, diabetes, valvular heart disease, mechanical heart valve, pregnancy or lactation, spontaneous drainage, medication use (especially antibiotics), and history of sensitivity to ciprofloxacin or metronidazole

all patients received preoperative ceftriaxone (1 g) once, just before anesthesia induction

98% of patients completed follow-up and 100% were analyzed by intention-to-treat

comparing postoperative metronidazole plus ciprofloxacin vs. no antibiotics
postoperative fistula development at 3 months in 14.1% vs. 30% (p < 0.001, NNT 7)

factors positively or negatively associated with postoperative fistula development
postoperative metronidazole plus ciprofloxacin associated with decreased postoperative fistula development (odds ratio 0.371, 95% CI 0.196-0.703)

male sex associated with increased postoperative fistula development (odds ratio 3.11, 95% CI 1.31-7.38)

Reference - Surgery 2017 Nov;162(5):1017, commentary can be found in Can J Surg 2020 Aug 19;63(4):E362
STUDY SUMMARY 研究總結
amoxicillin-clavulanate for 10 days after surgical drainage not associated with improved healing of anorectal abscess and may increase fistula formation by about 15% in adults
手術引流后阿莫西林-克拉維酸 10 天與肛門直腸膿腫癒合改善無關，成人瘺管形成可能增加約 15%
RANDOMIZED TRIAL: Dis Colon Rectum 2011 Aug;54(8):923
隨機試驗： Dis Colon Rectum 2011 年 8 月;54（8）：923
based on randomized trial without intention-to-treat analysis

183 adults (mean age 37.6 years and 78.1% men) having drainage of anorectal abscess randomized after surgery to amoxicillin-clavulanate 875 mg-125 mg orally twice daily vs. placebo for 10 days and followed for 1 year

anorectal abscesses were perianal, intersphincteric, or ischiorectal

17% dropped out of study and were excluded from analyses

fistula formation in 37.3% with amoxicillin-clavulanate vs. 22.4% with placebo (p = 0.044, NNH 6)

compared with perianal abscess, risk of fistula formation increased in patients with intersphincteric abscess or ischiorectal abscess (p = 0.001)

Reference - Dis Colon Rectum 2011 Aug;54(8):923

Surgery and Procedures 手術和程式

Anorectal Abscess 肛門直腸膿腫

surgical drainage (ASCRS Grade 1C; SICCR 1B)^1
,3
,4
手術引流（ASCRS 1C 級 ;SICCR 1B）^1
、3
、4
- acute abscess is always an indication for emergency surgery (German S3 Strong clinical consensus)
  急性膿腫始終是急診手術的指征（德國 S3 Strong 臨床共識）
- surgical drainage is the primary treatment of anorectal abscess
  手術引流是肛門直腸膿腫的主要治療方法
- surgical drainage should be performed under regional or general anesthesia
  手術引流應在區域或全身麻醉下進行
  - for superficial abscesses, local anesthesia may be feasible
    對於淺表膿腫，局部麻醉可能是可行的
  - for more complex abscesses, perform under general anesthesia, sedation, or local anesthesia in operating room
    對於更複雜的膿腫，在手術室進行全身麻醉、鎮靜或局部麻醉
- access point (transrectal or perianal) depends on abscess location; goal of treatment is complete drainage while preserving sphincter structures (German S3 Strong clinical consensus)
  入口（經直腸或肛周）取決於膿腫位置;治療目標是在保留括約肌結構的同時完全引流（德國 S3 Strong 臨床共識）
- for subanodermal or ischioanal abscesses
  用於肛門下皮或坐骨肛門膿腫
  - use perianal incision or an excision removing an oval shape of tissue (preferable for easier placement of drainage)
    使用肛周切口或切除橢圓形組織（最好更容易引流）
  - incision should run parallel to sphincter ani externus muscle fibers
    切口應平行於括約肌 ANI 外肌纖維
- surgical drainage reported to have 3%-44% recurrence rate (median reported to be around 13%)
  據報導，手術引流的復發率為 3%-44%（據報導中位數約為 13%）
- keep incision as close as possible to anal verge while still providing adequate drainage, in order to minimize length of potential fistula
  使切口盡可能靠近肛緣，同時仍提供足夠的引流，以盡量減少潛在瘺管的長度
- adequately sized elliptical incisions generally do not require postoperative wound packing
  大小合適的橢圓切口通常不需要術后傷口填塞
- incision and placement of catheter for drainage, with subsequent removal after cavity closure (usually by 3-10 days) is also an option
  切開和放置導管引流，然後在腔體閉合后（通常 3-10 天）取出也是一種選擇
- for post-operative management of abscess or fistula (German S3 Grade 4, Level b)⁴
  用於膿腫或瘺管的術后管理（德國 S3 4 級，b 級）⁴
  - rinse anal area regularly with water
    定期用水沖洗肛門區域
  - local antiseptics may be associated with risk of cytotoxicity
    局部消毒劑可能與細胞毒性風險有關
in patients with anorectal abscess plus fistula¹
在肛門直腸膿腫加瘺管 ¹
- if simple fistula, consider concomitant fistulotomy at time of surgical drainage (ASCRS Grade 2B)
  如果是單純性瘺管，則考慮在手術引流時同時進行瘺管切開術（ASCRS 2B 級）
- for complex fistula or unclear fistulas, consider placement of a draining seton, followed by a second procedure for closure (such as fistulotomy) after infection cleared (German S3 Grade A, Level 1a)
  對於複雜瘺管或不清楚的瘺管，考慮放置引流掛線，然後在感染清除後進行第二次閉合手術（例如瘺管切開術）（德國 S3 A 級，1a 級）
- consider the following draining techniques for abscess associated with fistula³
  考慮以下引流技術治療與瘺管 ³ 相關的膿腫
  - for true supralevator abscess associated with intersphincteric fistula
    用於與括約肌間瘺相關的真性提肌上膿腫
    - drain transanally into upper anal canal with limited division of internal sphincter
      經肛門引流至肛管上部，內括約肌分裂有限
    - draining through ischioanal fossa may result in suprasphincteric fistula
      經坐骨肛窩引流可能導致括約肌上瘺
  - for infralevator abscess, drain through ischioanal fossa
    對於下肛膿腫，通過坐骨肛窩引流
  - for ischiorectal fossa abscess associated with transsphincteric fistula do not drain through rectum, as this may result in suprasphincteric fistula
    對於坐骨直腸窩，與經括約肌瘺相關的膿腫不會通過直腸引流，因為這可能導致括約肌上瘺
  - for ischiorectal abscess horseshoe extension associated with transsphincteric fistula, create counter-incision in skin of contralateral ischiorectal fossa to ensure complete drainage
    對於與經括約肌瘺相關的坐骨直腸膿腫馬蹄形擴展，在對側坐骨直腸窩的皮膚上創建反向切口以確保完全引流
consider wound culturing post procedure in patients with¹
對於 ¹
- recurrent infection or nonhealing wounds
  復發性感染或不癒合傷口
- underlying HIV infection and either concomitant infections or atypical microbes such as tuberculosis
  潛在的 HIV 感染和伴隨感染或非典型微生物，例如結核病
risk of abscess recurrence or secondary fistula formation is reported to be low, and caused by insufficient drainage (German S3 Grade B, Level 4)⁴
據報導，膿腫復發或繼發性瘺管形成的風險較低，並且是由引流不足引起的（德國 S3 B 級，4 級）⁴
postoperative packing of perianal abscess cavities
肛周膿腫腔的術后填塞
- STUDY SUMMARY 研究總結
  simple external wound dressing may reduce postoperative pain and improve wound healing compared to perianal abscess cavity packing in adults who had incision and drainage of primary perianal abscesses
  對於原發性肛周膿腫切開引流的成人，與肛周膿腫腔填塞相比，簡單的外部傷口敷料可減輕術后疼痛並改善傷口癒合
  RANDOMIZED TRIAL: Br J Surg 2022 Sep 9;109(10):951
  隨機試驗：Br J Surg 2022 年 9 月 9 日;109（10）：951
  based on randomized trial with high dropout rate
  
  433 adults (median age 42 years, 67% male) who had incision and drainage of primary perianal abscess of cryptoglandular origin were randomized to postoperative nonpacking (simple external dressing only) vs. packing of perianal abscess cavities and followed for 6 months
  in packing group, frequency, type of dressing, and duration of packing was left to discretion of treating nurses
  
  all patients received standard intraoperative wound packing, removed within 24 hours after surgery
  
  exclusion criteria included perianal fistula, Fournier gangrene, and horseshoe abscess
  
  primary outcome was mean maximum pain score over first 10 postoperative days assessed on visual analog scale (VAS) (score range 0-100 points, with higher scores indicating more severe pain)
  
  63% with available data were included in primary outcome analysis
  
  comparing simple wound dressing vs. packing of perianal abscess cavities
  mean maximum VAS pain score over 10 days 28.2 points vs. 38.2 points (p < 0.001)
  
  mean VAS pain score
  32 points vs. 42 points during dressing change (p < 0.001)
  
  26 points vs. 32 points after dressing change (p = 0.007)
  
  wound healing at 6 months in 79% vs. 69% (p = 0.046, NNT 10)
  
  perianal fistula at 6 months in 11% vs. 15% (not significant)
  
  abscess recurrence at 6 months in 6% vs. 3% (not significant)
  
  no significant differences in health-related quality of life scores
  
  Reference - PPAC2 trial (Br J Surg 2022 Sep 9;109(10):951)
- earlier Cochrane review found insufficient evidence to determine if internal dressings improve healing or reduce adverse events after incision and drainage of perianal abscesses (Cochrane Database Syst Rev 2016 Aug 26;(8):CD011193)
  早期的 Cochrane 綜述發現，沒有足夠的證據來確定內部敷料是否能促進肛周膿腫切開引流後的癒合或減少不良事件（Cochrane 資料庫系統修訂版，2016 年 8 月 26 日;（8）：CD011193）
STUDY SUMMARY 研究總結
fistula surgery at time of perianal abscess drainage associated with lower rates of abscess or fistula recurrence and repeat surgery than drainage alone, but also with nonsignificantly higher rates of fecal incontinence
肛周膿腫引流時的瘺管手術與單獨引流相比，膿腫或瘺管復發和重複手術的發生率較低，但大便失禁的發生率也無統計學意義地升高
COCHRANE REVIEW: Cochrane Database Syst Rev 2010 Jul 7;(7):CD006827
COCHRANE 評價： Cochrane 資料庫系統修訂版 2010 年 7 月 7 日;（7）：CD006827
based on Cochrane review of trials with unclear allocation concealment

systematic review of 6 trials comparing incision and drainage of perianal abscess alone vs. incision and drainage in addition to fistulotomy or fistulectomy in 479 patients with abscess and high or low fistula without history of Crohn disease

follow-up was ≥ 12 months in 5 studies for which follow-up was reported

fistula surgery at time of abscess draining associated with
reduced risk of abscess/fistula recurrence or repeat surgery in 6 trials with 479 patients
risk ratio (RR) 0.13, 95% CI 0.07-0.24

NNT 4-5 with 32% event rate in controls

nonsignificantly increased fecal incontinence at 1 year (RR 3.06, 95% CI 0.7-13.45)

conflicting results evaluating duration of wound healing in 2 studies with 90 patients

Reference - Cochrane Database Syst Rev 2010 Jul 7;(7):CD006827
STUDY SUMMARY 研究總結
surgical drainage of perianal abscess may be associated with increased risk for fistula in ano in infants ≤ 1 year old
肛周膿腫手術引流可能與 1 ≤ 歲嬰兒 ANO 瘺管風險增加有關
COHORT STUDY: Pediatrics 2007 Sep;120(3):e548
佇列研究：兒科 2007 年 9 月;120（3）：e548
based on retrospective cohort study

140 children ≤ 1 year old (mean age 4 months) presenting with perianal abscess from 1995 to 2005 were assessed for treatment outcomes
83 patients had abscess drained

57 patients received conservative management without drainage

42% developed fistula in ano

fistula in ano formation associated with abscess drainage (60% of drained group developed fistula in ano, compared to 15.8% of nondrained group, odds ratio [OR] 5, 95% CI 2-13, NNH 2)

antibiotic use associated with decreased risk of fistula in ano formation (OR 0.14, 95% CI 0.06-0.33)

Reference - Pediatrics 2007 Sep;120(3):e548, editorial can be found in Pediatrics 2007 Sep;120(3):646, commentary can be found in Pediatrics 2008 Feb;121(2):447

Simple Fistula in Ano
Ano 中的簡單瘺管

recommendations for management of simple, low fistula in ano from the American Society of Colon and Rectal Surgeons (ASCRS), Italian Society of Colorectal Surgery practice parameters, and German S3 guidelines^1
,3
,4
美國結腸直腸外科醫師協會（ASCRS）、義大利結直腸外科學會實踐參數和德國 S3 指南對 ANO 單純性低位瘺管的管理建議 ^1,3,4
- in patients with normal anal sphincter function with simple, low fistula in ano, consider fistulotomy performed by experienced surgeon (ASCRS Grade 1B; SICCR 1B; German S3 Grade A, Level 1a)
  對於肛門括約肌功能正常但 ANO 中單純性低位瘺管的患者，考慮由經驗豐富的外科醫生進行瘺管切開術（ASCRS 1B 級 ;SICCR 1B; 德語 S3 A 級，1a 級）
- marsupialization may improve wound healing after fistulotomy in patients with simple fistula in ano (SICCR 1B)
  造袋術可改善 ANO 單純性瘺管患者瘺管切開術後的傷口癒合（SICCR 1B）
- for fistulotomy with either diathermy or radiofrequency, the energy source does not appear to influence procedure results for continence, but radiofrequency is associated with less and pain and faster healing time (SICCR 2B)
  對於透熱療法或射頻瘺管切開術，能量來源似乎不會影響尿失禁的手術結果，但射頻與較少和疼痛以及更快的癒合時間有關（SICCR 2B）
- fistulotomy is not appropriate for patients with preoperative incontinence, recurrent disease, complex fistulas, or prior fistula or anorectal surgery
  瘺管切開術不適用於術前尿失禁、復發性疾病、複雜瘺管或既往瘺管或肛門直腸手術的患者
- alternative options include
  替代選項包括
  - ligation of intersphincteric fistula tract (LIFT) for simple and complex fistulas (ASCRS Grade 1B; SICCR 1B; German S3 Grade A, Level 1b)
    用於簡單性和複雜瘺管的括約肌間瘺束結紮術（LIFT）（ASCRS 1B 級 ;SICCR 1B; 德語 S3 A 級，1b 級）
  - debridement plus fibrin glue (sealant) injection (ASCRS Grade 2B; SICCR 2C; German S3 Grade B, Level 1b)
    清創加纖維蛋白膠（密封劑）注射（ASCRS 2B 級 ;SICCR 2C; 德語 S3 B 級，1b 級）
  - anal fistula plugs such as
    肛瘺栓，如
    - Surgisis anal fistula plug (German S3 Grade B, Level 1b)
      手術肛瘺栓（德國 S3 B 級，1b 級）
    - Gore Bio-A fistula plug (German S3 Grade C, Level 4)
      Gore Bio-A 瘺管栓（德國 S3 C 級，4 級）
- generally, alternative options are more expensive than fistulotomy, which typically cures simple fistula in ano, so alternative options usually only considered for patients at high risk of postoperative incontinence
  一般來說，替代選擇比瘺管切開術更昂貴，瘺管切開術通常可以治癒 ANO 中的單純性瘺管，因此通常只考慮用於術后尿失禁風險高的患者
- recommendations regarding procedures to avoid for simple fistula in ano
  關於 ANO 中單純性瘺管應避免的手術建議
  - do not use loose inert or chemical setons, which are associated with longer healing times and more postoperative pain (SICCR 1B)
    不要使用鬆散的惰性或化學掛傷劑，這會導致更長的癒合時間和更多的術后疼痛（SICCR 1B）
  - do not perform fistulectomy (SICCR 1B)
    不進行瘺管切除術（SICCR 1B）
- no special bowel preparation required for fistula excision or seton placement; effect of preoperative bowel cleaning or post-operative delay or prevention of bowel movements on healing rates and times is unclear (German S3 Grade A, Level 1a)
  瘺管切除或掛線放置不需要特殊的腸道準備;術前腸道清潔或術后延遲或預防排便對癒合速度和時間的影響尚不清楚（德國 S3 A 級，1a 級）
fistulotomy^1
,2
,3
,4
瘺管切開術 ^1,2,3,4
- fistulotomy procedure involves laying open fistula tract through division of superficial tissue
  瘺管切開術包括通過分裂淺表組織鋪設開放的瘺管
- most commonly used for submucosal (low) fistulas
  最常用於粘膜下（低）瘺
- associated with reported 74%-100% success rate; fistulotomy for ow fistulas are reported to have success rate close to 100%
  與報告的 74%-100% 成功率相關;據報導，OW 瘺管的瘺管切開術成功率接近 100%
- risk of postoperative impaired continence is reported to be 0%-45%
  據報導，術后尿失禁的風險為0%-45%
  - risk of postoperative incontinence increases with the amount of sphincter transected; there is no risk of incontinence if sphincteric mechanism not involved
    術后失禁的風險隨著括約肌橫切量的增加而增加;如果不涉及括約肌機制，則沒有尿失禁的風險
  - goal should be to avoid extensive division of sphincter muscle
    目標應為避免括約肌的廣泛分裂
- may include marsupialization, which involves adhering wound opening to skin edges with sutures after laying open tract (Colorectal Dis 2006 Jan;8(1):11)
  可能包括有袋化，這涉及在鋪設開放道後用縫合線將傷口開口粘附在皮膚邊緣（結直腸疾病 2006 年 1 月;8（1）：11）
- STUDY SUMMARY 研究總結
  81% reported success rate of fistulotomy at 5 years in adults with low perianal fistula
  81% 的患者報告了低位肛周瘺成人 5 年瘺管切開術的成功率
  
  CASE SERIES: Int J Colorectal Dis 2015 Feb;30(2):213
  病例系列：國際結直腸疾病雜誌 2015 年 2 月;30（2）：213
  based on case series
  
  537 adults with low perianal fistula received fistulotomy
  
  83.6% of patients had successful healing
  
  after secondary procedure for recurrence, secondary healing rate was 90.3%
  
  at 5 years fistula healing rate was 81%
  
  major incontinence reported in 28% of patients (only 26.3% of patients had perfect continence [defined as Vaizey score of 0])
  
  Reference - Int J Colorectal Dis 2015 Feb;30(2):213
fistulectomy¹
瘺管切除術 ¹
- fistula tract resection 瘺管切除術
- may include marsupialization
  可能包括有袋運動
- fistulectomy reported to be associated with longer healing times, larger defects, and increased risk for incontinence compared to fistulotomy, with similar recurrence rates for the 2 procedures
  據報導，與瘺管切開術相比，瘺管切除術與更長的癒合時間、更大的缺損和增加的尿失禁風險有關，兩種手術的復發率相似
fibrin glue injection plus debridement^1
,2
,4
纖維蛋白膠注射加清創術 ^1,2,4
- fibrin glue consists of fibrinogen, thrombin, and calcium
  纖維蛋白膠由纖維蛋白原、凝血酶和鈣組成
- glue injected into fistula to induce clot formation to promote healing, and subsequently encourage collagen fiber and healthy tissue growth
  將膠水注射到瘺管中以誘導凝塊形成，從而促進癒合，從而促進膠原纖維和健康組織的生長
- variable rate of effectiveness with 40%-78% reported healing rates for fibrin glue in simple fistulas
  纖維蛋白膠在簡單瘺管中的有效率差異，據報導 40%-78% 的治癒率
- reported advantages of fibrin glue include ease of use, repeatability, and avoidance of sphincter division (particularly for patients at high risk of postoperative incontinence)
  據報導，纖維蛋白膠的優點包括易於使用、可重複性和避免括約肌分裂（特別是對於術后尿失禁風險高的患者）
- can preserve sphincter function
  可以保留括約肌功能
- has been used in simple and complex fistulas
  已用於簡單性和複雜性瘺管
- see also Fibrin glue section
  另見纖維蛋白膠 section
anal fistula plug^1
,2
,4
肛瘺栓 ^1,2,4
- consists of bioprosthetic plug used to close primary internal opening and serves as matrix for fistula tract obliteration
  由用於關閉原發性內部開口的生物瓣塞組成，並用作瘺管閉塞的基質
- considered sphincter-sparing procedure
  考慮保留括約肌的手術
- reported 70%-100% success rate in low-lying fistulas, though may be less in complex fistulas
  據報導，在低位瘺管中成功率為 70%-100%，但在複雜瘺管中可能更低
- see also Anal fistula plugs section
  另見肛瘺栓部分
STUDY SUMMARY 研究總結
marsupialization of edges of laid-open track during fistulotomy shortens time to complete healing in adults with simple anal fistula
瘺管切開術中鋪設軌道邊緣的造袋作用縮短了成人單純性肛瘺完全癒合的時間
RANDOMIZED TRIAL: Ann R Coll Surg Engl 2019 Jun 3 early online
隨機試驗： Ann R Coll Surg Engl 2019 Jun 3 提前在線
Gastrointestinal_Disorders Surgery_and_Proceduresmarsupialization of edges of laid-open track during fistulotomy shortens time to complete healing in adults with simple anal fistula (Ann R Coll Surg Engl 2019 Jun 3 early online)07/25/2019 12:10:50 PM
based on randomized trial with lack of generalizability

62 adults (mean age 40 years, 81% men) having fistulotomy for simple anal fistula were randomized to marsupialization of edges of laid-open track vs. no marsupialization and followed for 1 year

60 patients (97%) completed follow-up and were included in analysis

trial was performed at single center limiting generalizability

comparing with marsupialization vs. no marsupialization
mean time to complete healing 5.1 weeks vs. 6.7 weeks (p < 0.0001)

mean operation time 18.4 minutes vs. 16.8 minutes (p = 0.054)

recurrence of anal fistula in 0% vs. 3.3% (not significant)

complications in 6.6% vs. 13.3% (not significant)

no significant differences in postoperative pain at 1 week or physical, social, or sexual activity after treatment

Reference - Ann R Coll Surg Engl 2019 Jun 3 early online
STUDY SUMMARY 研究總結
insufficient evidence to recommend any particular procedure over others for simple anorectal fistula
沒有足夠的證據推薦任何特定手術治療單純性肛門直腸瘺
COCHRANE REVIEW: Cochrane Database Syst Rev 2010 May 12;(5):CD006319
COCHRANE 評價： Cochrane 資料庫系統修訂版 2010 年 5 月 12 日;（5）：CD006319
based on Cochrane review

systematic review of 10 randomized trials and 8 nonrandomized trials comparing different operative procedures for simple anorectal fistula (intersphincteric, low and high transsphincteric fistulae that are cryptoglandular in origin)

no significant differences in recurrence or incontinence rates in randomized trials comparing
internal anal sphincter-preserving seton vs. conventional fistulotomy in 1 trial with 100 patients (summarized)

fibrin glue vs. conventional fistulotomy plus seton in 1 trial with 13 patients

radiofrequency ablation vs. conventional fistulotomy in analysis of 2 trials with 122 patients

fistulotomy vs. marsupialization fistulotomy in analysis of 2 trials with 137 patients

advancement flap vs. fibrin glue with flap repair in 1 trial with 58 patients

fistulotomy vs. fistulectomy in 1 trial with 45 patients

Reference - Cochrane Database Syst Rev 2010 May 12;(5):CD006319

Ayurvedic cutting seton treatment appears as effective as fistulotomy for patients with low fistula in ano
based on randomized trial without intention-to-treat analysis

100 patients with low fistula in ano randomized to cutting seton vs. fistulotomy

cutting seton associated with more immediate postoperative pain (within 2-4 days), but no significant difference in subsequent pain

no significant difference in time to healing, complications, or functional outcome

Reference - Tech Coloproctol 2001 Dec;5(3):137

Complex Fistula in Ano Ano 中的複雜瘺管

Recommendations for Complex Fistula
複雜瘺管的建議

recommendations for management of complex fistula in ano from American Society of Colon and Rectal Surgeons (ASCRS), Italian Society of Colorectal Surgery (SICCR) practice parameters, and German S3 guidelines^1
,3
,4
美國結腸直腸外科醫師協會（ASCRS）、義大利結直腸外科學會（SICCR）實踐參數和德國 S3 指南對 ANO 複雜瘺管管理的建議 ^1,3,4
- goal of management is to eliminate the internal opening of the fistula and any associated epithelialized tracks while maintaining anal sphincter function
  治療的目標是消除瘺管的內部開口和任何相關的上皮化軌道，同時保持肛門括約肌功能
- obtain imaging prior to determining management to identify occult internal openings, secondary tracts or abscesses, and to evaluate fistula's relationship to sphincter complex (ASCRS Grade 1B)
  在確定治療之前進行影像學檢查，以識別隱匿性內部開口、繼發性束或膿腫，並評估瘺管與括約肌複合體的關係（ASCRS 1B 級）
- a sphincter-sparing procedure should be chosen, and several options are available (German S3 Grade A, Level 1a)
  應選擇保留括約肌的手術，並且有幾種選擇（德國 S3 A 級，1a 級）
- sphincter-sparing procedure options with strong recommendation for treatment of complex fistula in ano include the following
  強烈推薦治療 ANO 複雜瘺管的保留括約肌手術選擇包括
  - endoanal (endorectal) advancement flaps (ASCRS Grade 1B; SICCR 1B)
    肛門內（直腸內）前移皮瓣（ASCRS 1B 級 ;SICCR 1B）
    - many modifications exist, including curved incisions, rhomboid flaps, and anorectal flaps with proximal advancement
      存在許多改變，包括彎曲的切口、菱形皮瓣和肛門直腸皮瓣伴近端推進
    - consider diverting stoma based on individual clinical factors, such as for persistent perianal infection
      根據個體臨床因素考慮改道造口，例如持續性肛周感染
  - ligation of intersphincteric fistula tract (LIFT) (ASCRS Grade 1B; SICCR 1B)
    括約肌間瘺束結紮術（LIFT）（ASCRS 1B 級 ;SICCR 1B）
    - LIFT may be used for simple or complex fistulas
      LIFT 可用於簡單或複雜的瘺管
    - draining seton may be used prior to procedure
      手術前可以使用引流掛線
- sphincter-sparing procedure options with weak recommendations or low-quality evidence for treatment of complex fistula in ano include the following
  治療 ANO 複雜瘺管的保留括約肌手術選擇包括以下內容
  - fibrin glue injection after debridement (ASCRS Grade 2B; SICCR 2B; German S3 Grade B, Level 1b)
    清創后注射纖維蛋白膠（ASCRS 2B 級 ;SICCR 2B; 德語 S3 B 級，1b 級）
    - fibrin glue relatively ineffective for fisula-in-ano
      纖維蛋白膠對 Fisula-in-ANO 相對無效
    - considered an option due to sphincter-preserving capabilities
      由於保留括約肌的能力，被認為是一種選擇
  - anal fistula plug (ASCRS Grade 2B; SICCR 1C)
    肛瘺栓（ASCRS 2B 級 ;SICCR 1C）
    - fistula plug relatively ineffective for complex fisula-in-ano
      瘺管栓對複雜的肛瘺管炎相對無效
    - considered an option due to sphincter-preserving capabilities
      由於保留括約肌的能力，被認為是一種選擇
    - options include 選項包括
      - Surgisis anal fistula plug (German S3 Grade B, Level 1b)
        手術肛瘺栓（德國 S3 B 級，1b 級）
      - Gore Bio-A fistula plug (German S3 Grade C, Level 4)
        Gore Bio-A 瘺管栓（德國 S3 C 級，4 級）
  - video-assisted debridement and cauterization of fistula tract with closure of the internal opening may be used for complex fistula in ano (SICCR 2C; German S3 Grade 0, Level 5)
    視頻輔助清創和瘺管燒灼術並關閉內部開口可用於 ANO 中的複雜瘺管（SICCR 2C; 德語 S3 0 級，5 級）
  - laser ablation of the fistulous track with and without closure of the internal opening may be used for high fistulas (SICCR 2C)
    瘺管軌道鐳射消融術（內開口閉合和不閉合）可用於高位瘺管（SICCR 2C）
  - over-the-scope-clip ("bear-claw clip") has mixed evidence (German S3 Grade 0, Level 4)
    over-the-scope-clip （“bear-claw clip”）證據參差不齊（German S3 Grade 0， Level 4）
  - collagen injection (German S3 Grade C, Level 4)
    膠原蛋白注射液（德國 S3 C 級，4 級）
  - fistula excision with direct sphincter reconstruction may yield similar outcomes as advancement flaps procedures, but limited evidence to recommend this procedure (German S3 Grade A, Level 1b)
    瘺管切除術聯合直接括約肌重建可能產生與前移皮瓣手術相似的結果，但推薦該手術的證據有限（德國 S3 A 級，1b 級）
- sphincter-sacrificing procedures generally not recommended for complex fistulas or only recommended with caution
  通常不建議將括約肌犧牲手術用於複雜瘺管，或僅謹慎推薦
  - cutting seton 切割掛線
    - ASCRS suggests use of cutting seton followed by secondary procedure may be used with caution for complex cryptoglandular anal fistulas (ASCRS Grade 2B) due to high success rates, but with caveat that rates of reported incontinence are highly variable due to fistula type and definitions of fecal incontinence in studies
      ASCRS 建議，由於成功率高，對於複雜的隱腺肛瘺（ASCRS 2B 級），可以謹慎使用切割掛線后進行二次手術，但需要注意的是，由於研究中瘺管類型和大便失禁的定義，報告的尿失禁發生率差異很大
    - German S3 guidelines consider reported incontinence rates of 0%-92% as too high to recommend use of cutting setons (German S3 Grade B, Level 2a)
      德國 S3 指南認為報告的 0%-92% 失禁率太高，不建議使用切割墊（德國 S3 B 級，2a 級）
  - fistulotomy generally reserved for simple anal fistulas
    瘺管切開術通常僅用於單純性肛瘺

Advancement Flaps 進度襟翼

endoanal, endorectal, or mucosal advancement flaps^1
,2
,3
,4
肛門內、直腸內或粘膜前移皮瓣 ^1,2,3,4
- involves curettage of the tract, suturing internal opening, and covering the site of the internal opening with healthy anorectal mucosa, submucosa, or muscle from proximal site
  包括刮除尿道、縫合內部開口，以及用健康的肛門直腸黏膜、黏膜下層或近端部位的肌肉覆蓋內部開口部位
- many modifications exist, including curved incisions, rhomboid flaps, and anorectal flaps with proximal advancement
  存在許多改變，包括彎曲的切口、菱形皮瓣和肛門直腸皮瓣伴近端推進
- used for high or complex anorectal fistulas
  用於高位或複雜肛門直腸瘺
- success rates reported fro 0%-63%
  報告的成功率為 0%-63%
- reported 13%-56% recurrence rate; reported overall 30%-70% success rate
  報告的復發率為 13%-56%;報告的總體成功率為 30%-70%
- 7%-38% of patients report subsequent mild-to-moderate incontinence
  7%-38% 的患者報告隨後出現輕度至中度尿失禁
- risk factors for treatment failure include radiation, underlying Crohn disease, active proctitis, rectovaginal fistula, malignancy, and history of attempted repairs
  治療失敗的危險因素包括放療、潛在克羅恩病、活動性直腸炎、直腸陰道瘺、惡性腫瘤和嘗試修復史
- STUDY SUMMARY 研究總結
  endorectal advancement flap reported to be effective for complex cryptoglandular or Crohn fistula in ano
  據報導，直腸內前移皮瓣對 ano 中的複雜隱腺或克羅恩瘺有效
  SYSTEMATIC REVIEW: Dis Colon Rectum 2010 Apr;53(4):486
  系統評價： Dis 結腸直腸 2010 年 4 月;53（4）：486
  based on systematic review of case series studies
  
  systematic review of 35 studies evaluating endorectal advancement flap for treatment of anorectal fistulas in 1,654 patients
  1,335 patients had fistula of cryptoglandular origin, and 91 patients had fistula of Crohn disease origin
  
  flaps consisted of mucosa in 8 studies, partial-thickness in 22 studies, and full-thickness flaps in 5 studies
  
  for cryptoglandular fistulas
  weighted success rate 80.8% (range 24%-100%)
  
  weighted incontinence rate 13.3% (range 0%-35%)
  
  for Crohn fistula
  weighted success rate 64% (range 33%-93%)
  
  weighted incontinence rate 9.4% (range 0%-28.6%)
  
  Reference - Dis Colon Rectum 2010 Apr;53(4):486, commentary can be found in Dis Colon Rectum 2011 May;54(5):648

Evidence Synopsis 證據概要

LIFT and advancement flaps may have similar healing and recurrence rates, but LIFT is generally a simpler procedure to perform.
LIFT 和前移皮瓣可能具有相似的癒合和復發率，但 LIFT 通常是一種更簡單的手術。

STUDY SUMMARY 研究總結
LIFT procedure may yield similar healing rates for high transsphincteric fistulas as mucosal advancement flap, and LIFT might preserve continence more effectively with less inpatient care
對於高位經括約肌瘺，LIFT 手術可能產生與粘膜推進皮瓣相似的癒合率，並且 LIFT 可能會以較少的住院護理更有效地保持節制

RANDOMIZED TRIAL: Dis Colon Rectum 2014 Oct;57(10):1202
隨機試驗： Dis Colon Rectum 2014 年 10 月;57（10）：1202
based on randomized trial without blinding

70 patients aged ≥ 18 years with high transsphincteric cryptoglandular anal fistulas were randomized to ligation of intersphincteric fistula track (LIFT) vs. mucosal advancement flap (MAF)
LIFT performed as outpatient or with 1 day inpatient, and patients allowed full diet postoperatively

MAF required inpatient admission for 2 days with nothing by mouth for first post-op day

all patients received antibiotics for 1 week post-op

comparing LIFT vs. MAF
complete healing of fistula in 94.2% vs. 91.4% (not significant)

mean healing time 26.6 vs. 38.1 days (p = 0.0004)

recurrent fistula in 21.2% vs. 28.1% (not significant)

at 4 weeks follow-up, worsened continence in 0% vs. 14% (p = 0.054)

Reference - Dis Colon Rectum 2014 Oct;57(10):1202
STUDY SUMMARY 研究總結
LIFT associated with similar healing and recurrence as advancement flap procedure, and may allow for faster return to normal activities
LIFT 與推進皮瓣手術類似的癒合和復發相關，並且可能允許更快地恢復正常活動
RANDOMIZED TRIAL: Am J Surg 2012 Sep;204(3):283
隨機試驗：Am J Surg 2012 年 9 月;204（3）：283
based on small randomized trial

39 patients with complex fistula in ano randomized to LIFT vs. anorectal advancement flap (ARAF)

all patients had draining seton prior to LIFT or ARAF

comparing LIFT vs. ARAF
mean time of procedure 10 vs. 42.5 minutes (p < 0.05)

healing by 1 month in 68% vs. 85% (not significant)

recurrence in 8% vs. 7% (not significant)

no differences in continence

time to return to normal activities 1 week vs. 2 weeks (p = 0.016)

complication of secondary bleed in 4% with LIFT vs. no complications with ARAF

Reference - Am J Surg 2012 Sep;204(3):283

Ligation of Intersphincteric Fistula Tract (LIFT)
括約肌間瘺束結紮術（LIFT）

ligation of intersphincteric fistula tract (LIFT)^1
,2
,4
括約肌間瘺束結紮術（LIFT）^1,2,4
- sphincter-sparing procedure involving ligation and division of fistula tract in intersphincteric space, used most often for high or complex anorectal fistulas
  保留括約肌的手術，涉及括約肌間隙瘺管的結紮和分裂，最常用於高位或複雜的肛門直腸瘺
  - typical procedure has ≥ 8 weeks seton placement to induce fibrosis, followed by intersphincteric approach to identify, ligand, and divide tract with possible internal opening closure and external opening widening for drainage
    典型手術≥ 8 周的掛線放置以誘導纖維化，然後採用括約肌間方法來識別、配體和分割道，可能進行內部開口閉合和外部開口擴大以進行引流
  - procedure consists of intersphincteric approach to identify, ligate, and divide tract with possible internal opening closure and external opening widening (for drainage)
    手術包括括約肌間入路識別、結紮和分割道，可能進行內開口閉合和外開口加寬（用於引流）
- reported 40%-95% successful healing rate, and 6%-18% recurrence rate
  報告癒合成功率 40%-95%，復發率 6%-18%
- failure of LIFT reported to be associated with fistula tract length > 3 cm, prior fistula closure procedures, and obesity
  據報導，LIFT 失敗與瘺管長度 > 3 cm、既往瘺管閉合手術和肥胖有關
- STUDY SUMMARY 研究總結
  LIFT procedures reported to have 47%-95% success rate for healing transsphincteric perianal fistulas
  據報導，LIFT 手術治癒經括約肌肛周瘺的成功率為 47%-95%
  SYSTEMATIC REVIEW: Dis Colon Rectum 2015 Jun;58(6):604
  系統評價： Dis 結腸直腸 2015 年 6 月;58（6）：604
  based on systematic review of mostly case series
  
  systematic review of 26 studies (1 randomized trial and 25 observational studies) evaluating LIFT procedure for treatment of transsphincteric anal fistula
  
  classic LIFT procedure outcomes
  in pooling of 12 studies with 352 patients (follow-up duration 3-13 months)
  healing in 61%-94%, and time to healing ranged 4-8 weeks
  
  1 patient reported fecal incontinence
  
  healing in 60% at 2 months in 1 study with 15 patients with Crohn's disease-associated fistula; 1 patient had recurrence at 6 months, and 3 patients with healing developed new fistula at 1 year
  
  LIFT procedure without excision (tract is ligated and divided but not excised) outcomes in pooling of 5 studies with 130 patients (follow-up duration 3-19 months)
  healing in 47%-94% in pooling of 5 studies, and time to healing about 4 weeks in analysis of 2 studies with data on this outcome
  
  no changes in continence reported
  
  LIFT-plus procedure (classic LIFT plus coring out fistula tract from external opening to lateral border of external sphincter) outcomes in pooling of 4 studies with 104 patients (follow-up 5-19 months)
  healing in 76.5%-85%, and time to healing range 4-7 weeks
  
  no changes in continence reported
  
  LIFT-plus with intraoperative seton (removed at 3 postoperative weeks) reported to have 95% healing rate, with mean 7 weeks to healing and no changes in continence reported in analysis of 1 study with 21 patients
  
  LIFT-plus with transanal advancement flap reported to have 51% healing rate (median follow-up duration 15 months) in analysis of 1 study with 41 patients
  
  bioLIFT (LIFT procedure with bioprosthetic mesh between ligated ends of intersphincteric portion of tract) reported healing in 68.8%-94% (median follow-up range 6.5-15 months) with no change in continence reported in pooling of 2 studies with 44 patients
  
  Reference - Dis Colon Rectum 2015 Jun;58(6):604

Evidence Synopsis 證據概要

STUDY SUMMARY 研究總結
LIFT procedure may yield similar healing rates for high transsphincteric fistulas as mucosal advancement flap, and LIFT might preserve continence more effectively with less inpatient care
對於高位經括約肌瘺，LIFT 手術可能產生與粘膜推進皮瓣相似的癒合率，並且 LIFT 可能會以較少的住院護理更有效地保持節制

RANDOMIZED TRIAL: Dis Colon Rectum 2014 Oct;57(10):1202
隨機試驗： Dis Colon Rectum 2014 年 10 月;57（10）：1202
based on randomized trial without blinding

70 patients aged ≥ 18 years with high transsphincteric cryptoglandular anal fistulas were randomized to ligation of intersphincteric fistula track (LIFT) vs. mucosal advancement flap (MAF)
LIFT performed as outpatient or with 1 day inpatient, and patients allowed full diet postoperatively

MAF required inpatient admission for 2 days with nothing by mouth for first post-op day

all patients received antibiotics for 1 week post-op

comparing LIFT vs. MAF
complete healing of fistula in 94.2% vs. 91.4% (not significant)

mean healing time 26.6 vs. 38.1 days (p = 0.0004)

recurrent fistula in 21.2% vs. 28.1% (not significant)

at 4 weeks follow-up, worsened continence in 0% vs. 14% (p = 0.054)

Reference - Dis Colon Rectum 2014 Oct;57(10):1202
STUDY SUMMARY 研究總結
LIFT associated with similar healing and recurrence as advancement flap procedure, and may allow for faster return to normal activities
LIFT 與推進皮瓣手術類似的癒合和復發相關，並且可能允許更快地恢復正常活動
RANDOMIZED TRIAL: Am J Surg 2012 Sep;204(3):283
隨機試驗：Am J Surg 2012 年 9 月;204（3）：283
based on small randomized trial

39 patients with complex fistula in ano randomized to LIFT vs. anorectal advancement flap (ARAF)

all patients had draining seton prior to LIFT or ARAF

comparing LIFT vs. ARAF
mean time of procedure 10 vs. 42.5 minutes (p < 0.05)

healing by 1 month in 68% vs. 85% (not significant)

recurrence in 8% vs. 7% (not significant)

no differences in continence

time to return to normal activities 1 week vs. 2 weeks (p = 0.016)

complication of secondary bleed in 4% with LIFT vs. no complications with ARAF

Reference - Am J Surg 2012 Sep;204(3):283

Biomaterials 生物材料

Fibrin Glue 纖維蛋白膠

fibrin glue injection consists of curettage of fistula tract followed by injection with fibrin glue⁴
纖維蛋白膠注射包括瘺管刮除術，然後注射纖維蛋白膠 ⁴
STUDY SUMMARY 研究總結
addition of fibrin glue injection to advancement flap repair may increase fistula recurrence
在前移皮瓣修復術中加入纖維蛋白膠注射可能會增加瘺管復發
RANDOMIZED TRIAL: Dis Colon Rectum 2006 Nov;49(11):1736
隨機試驗： Dis 結腸直腸 2006 年 11 月;49（11）：1736
based on small randomized trial

58 patients with fistula in ano randomized to advancement flap repair plus fibrin glue injection vs. advancement flap repair alone and followed for median 2 years

32.6% of patients had fistula recurrence

comparing addition of fibrin glue vs. advancement flap procedure alone, recurrence in 46.4% vs. 20% (p < 0.05)

Reference - Dis Colon Rectum 2006 Nov;49(11):1736
STUDY SUMMARY 研究總結
fibrin glue injection reported to have 26% recurrence rate for complex fistula in ano at 6 years
據報導，纖維蛋白膠注射在 26 年時對 ANO 複雜瘺管的復發率為 6%
COHORT STUDY: Dis Colon Rectum 2011 Oct;54(10):1279
佇列研究：Dis 結腸直腸 2011 年 10 月;54（10）：1279
based on retrospective cohort study

60 patients with complex fistula in ano received fibrin glue injection of whom 32 were healed at 6 months and assessed for outcomes at mean 6.5 years

72% (23 patients) were available for long-term follow-up

at mean follow-up 6.5 years
74% were disease-free

26% had recurrence
4 patients required surgical intervention

2 patients treated with antibiotics only

recurrence occurred at mean 4 years (range 11 months to 6 years)

no patients reported incontinence

Reference - Dis Colon Rectum 2011 Oct;54(10):1279
STUDY SUMMARY 研究總結
fibrin glue injection appears less effective than seton therapy for healing medium or high anal fistulas, but may have lower rate of incontinence
纖維蛋白膠注射在治癒中度或高度肛瘺方面似乎不如 Seton 療法有效，但失禁的發生率可能較低
RANDOMIZED TRIAL: Colorectal Dis 2011 Jan;13(1):82
隨機試驗：結直腸疾病 2011 年 1 月;13（1）：82
based on small randomized trial

62 patients with medium or high transsphincteric anal fistula randomized to fibrin glue vs. seton treatment and followed for 1 year; seton treatment arm had only 24 patients

comparing fibrin glue vs. seton therapy, fibrin glue associated with
reduced healing rate (fistula cured in 39.5% vs. 87.5%, p = 0.0007)

decreased incontinence (p = 0.0001)

decreased hospital stay (p < 0.0001)

increased resting anal pressure (p = 0.003)

50% of patients retreated with fibrin glue after initial failure achieved fistula healing

Reference - Colorectal Dis 2011 Jan;13(1):82

Fistula Plugs 瘺管栓

fistula plugs are biomedical products designed to act as matrix for body's tissue to grow into with subsequent sealing of the fistula tract⁴
瘺管栓是一種生物醫學產品，旨在作為人體組織生長的基質，隨後封閉瘺管 ⁴
- inflamed tissue is not excised prior to insertion
  插入前未切除發炎的組織
- plug options include
  插頭選項包括
  - xenografts 異種移植物
    - derived from porcine small intestinal mucosa
      來源於豬小腸粘膜
    - includes Surgisis anal fistula plug (German S3 Grade B, Level 1b)
      包括 Surgisis 肛瘺栓（德國 S3 B 級，1b 級）
    - reported to have healing rate range 14%-93%
      據報導，治療速度範圍為 14%-93%
  - synthetics 合成
    - synthetics may have greater volume than other plugs to increase likelihood of fixation
      合成物可能比其他栓子具有更大的體積，以增加固定的可能性
    - includes Gore Bio-A fistula plug (German S3 Grade C, Level 4)
      包括 Gore Bio-A 瘺管栓（德國 S3 C 級，4 級）
    - reported healing rates range 16%-73%
      報告的治癒率範圍為 16%-73%
porcine anal fistula plug
豬肛瘺栓
- STUDY SUMMARY 研究總結
  addition of anofistula plug to LIFT associated with improved healing rate in patients with high transsphincteric anal fistula
  在 LIFT 中添加肛瘺栓與提高高位經括約肌肛瘺患者癒合率相關
  RANDOMIZED TRIAL: Ann Surg 2016 Dec;264(6):917
  隨機試驗： Ann Surg 2016 年 12 月;264（6）：917
  based on randomized trial without blinding
  
  239 patients (mean age 36 years) with high transsphincteric anal fistula (involvement of > 30% of external anal sphincter) randomized to LIFT plus porcine xenograft anal plug (LIFT-plug) vs. LIFT alone and followed for 6 months
  
  comparing LIFT-plug vs. LIFT alone
  primary healing in 94% vs. 84% (p < 0.001, NNT 12)
  
  median healing time 22 days vs. 30 days (p < 0.001)
  
  operative time 29 minutes vs. 27 minutes (p = 0.03)
  
  no reported incontinence or recurrence over 6-month follow-up
  
  no significant differences in postoperative pain scores across all time points
  
  Reference - Ann Surg 2016 Dec;264(6):917
- STUDY SUMMARY 研究總結
  xenograft anal fistula plug reported to be associated with overall 54% healing rate in patients without Crohn disease, though healing rate range from 2% to 86% in individual studies
  據報導，異種移植肛瘺栓與無克羅恩病患者的總體 54% 癒合率相關，儘管在個別研究中愈合率為 2%-86%
  
  SYSTEMATIC REVIEW: Dis Colon Rectum 2012 Mar;55(3):351
  系統評價： Dis 結腸直腸 2012 年 3 月;55（3）：351
  based on systematic review without assessment of study quality
  
  systematic review of 18 studies (2 randomized trials) and 2 abstracts evaluating Surgisis anal fistula plug (bioabsorbable porcine xenograft) for fistula closure and duration of healing in 530 patients (488 without Crohn disease)
  
  study size ranged from 4 to 60 patients, operative technique and perioperative care varied among studies, as did prevalence of complex vs. simple fistulae
  
  8.7% had plug extrusion
  
  pooled performance of anal fistula plug for fistula closure was 54% (95% CI 50%-59%) in 488 patients without Crohn disease
  
  fistula closure rate varied from 2% (95% CI 4%-48%) to 86% (95% CI 64%-97%) in individual studies
  
  no changes in continence reported
  
  Reference - Dis Colon Rectum 2012 Mar;55(3):351
- STUDY SUMMARY 研究總結
  anal fistula (xenograft) plug reported to be associated with 39%-70% success rate in patients with Crohn disease
  據報導，肛瘺（異種移植物）栓塞與克羅恩病患者 39%-70% 的成功率相關
  
  SYSTEMATIC REVIEW: Dis Colon Rectum 2012 Mar;55(3):351
  系統評價： Dis 結腸直腸 2012 年 3 月;55（3）：351
  based on systematic review without assessment of study quality
  
  systematic review of 18 studies (2 randomized trials) and 2 abstracts evaluating Surgisis anal fistula plug (bioabsorbable porcine xenograft) in 530 patients with anal fistula (42 patients had Crohn disease)
  
  8 studies included patients with Crohn disease
  
  study size ranged from 4 to 60 patients, operative technique and perioperative care varied among studies, as did prevalence of complex vs. simple fistulae
  
  8.7% had plug extrusion
  
  proportion of patients with Crohn disease achieving fistula closure was 55% (95% CI 39%-70%)
  
  no changes in continence reported
  
  Reference - Dis Colon Rectum 2012 Mar;55(3):351
synthetic anal fistula plug
合成肛瘺栓
- STUDY SUMMARY 研究總結
  delayed resorbable synthetic anal fistula plug healing rate reported to range from about 16% to 73%
  據報導，延遲可吸收合成痔瘺栓癒合率約為 16% 至 73%
  
  SYSTEMATIC REVIEW: Colorectal Dis 2016 Jan;18(1):37
  系統評價：結直腸疾病 2016 年 1 月;18（1）：37
  based on systematic review of observational studies
  
  systematic review evaluating anal fistula plug (GORE BIO-A) for simple or complex fistula in 6 studies with 221 patients (including patients with fistulae due to cryptoglandular origin, surgical trauma, Crohn disease, and HIV)
  
  healing rates for 187 patients with follow-up data ranged from 15.8%-72.7%
  
  minimal impact on continence reported
  
  Reference - Colorectal Dis 2016 Jan;18(1):37
STUDY SUMMARY 研究總結
anal fistula tract length > 4 cm associated with fistula plug treatment success
肛瘺束長度 > 4 cm，與瘺管栓治療成功相關
COHORT STUDY: Dis Colon Rectum 2010 Aug;53(8):1116
佇列研究： Dis 結腸直腸 2010 年 8 月;53（8）：1116
based on cohort study

41 patients with non-Crohn's related fistula in ano had tract evaluated with imaging and received fistula anal plug and followed for mean 2 years

complete closure achieved in 18 fistulas (43%)

23 fistula tracts were > 4 cm

comparing fistula tract length > 4 cm vs. length < 4 cm
complete closure achieved in 61% vs. 21%

risk ratio 2.8, 95% CI 1.14-7

sex, age, tract location, duration of seton, and follow-up duration each were not significantly associated with treatment outcome

Reference - Dis Colon Rectum 2010 Aug;53(8):1116, editorial can be found in Dis Colon Rectum 2010 Aug;53(8):1105
STUDY SUMMARY 研究總結
anal fistula plug and mucosal advancement flap associated with similar functional outcome, quality of life, and recurrence rates in patients with high transsphincteric perianal fistula
經括約肌肛周瘺患者的肛瘺栓和粘膜前移皮瓣與相似的功能結局、生活品質和復發率相關
RANDOMIZED TRIAL: Dis Colon Rectum 2011 Apr;54(4):387
隨機試驗： Dis 結腸直腸 2011 年 4 月;54（4）：387
based on small randomized trial

60 adults with cryptoglandular high transsphincteric perianal fistula randomized to anal fistula plug (31 patients) vs. mucosal advancement flap (29 patients)

recurrence at 11 months in 71% with anal fistula plug vs. 52% with mucosal advancement flap (not significant)

no significant differences in postoperative quality of life, pain, soiling, or incontinence score

Reference - Dis Colon Rectum 2011 Apr;54(4):387

Collagen Injection 膠原蛋白注射液

collagen injection has been used to fill fistula tracts, in addition to fibrin glue or on its own⁴
膠原蛋白注射已被用於填充瘺管，除了纖維蛋白膠或單獨使用 ⁴
STUDY SUMMARY 研究總結
collagen paste injection appears more effective for healing fistula tracts ≤ 4 cm without abscess than for healing longer tracts or those with abscess
膠原蛋白糊劑注射似乎對癒合 4 cm ≤無膿腫的瘺管比癒合較長的管或有膿腫的瘺管更有效
UNCONTROLLED TRIAL: Colorectal Dis 2017 May 11 early online
非對照試驗：結直腸疾病 2017 年 5 月 11 日提前上線
Gastrointestinal_Disorderscollagen paste injection appears more effective for healing fistula tracts ≤ 4 cm without abscess than for healing longer tracts or those with abscess (Colorectal Dis 2017 May 11 early online)08/28/2017 11:56:00 AM228493393
based on cohort analysis of uncontrolled trial

100 patients (70% male, mean age 47 years) with anal fistula received Permacol collagen paste injection into anal fistula tracts and were followed for 1 year

patient and fistula characteristics
39 patients had recurrent fistula; 86 patients had received prior treatment with draining/loose seton

27 fistulas were intersphincteric, 73 were transsphincteric, and 26 patients had fistulas involving ≥ 33% of sphincter; 11 fistulas had internal opening above dentate line, 66 were at dentate line, and 22 were below dentate line

mean fistula tract length 2.5 cm (range 0.5-6.5 cm)

24 patients dropped out, none had fistula healing at final assessment

median interval from procedure to return to work and resumption of normal activity was 7 days (range 1-35 days)

of patients with healed fistula tract
56.7% at 6 months

53.5% at 1 year

29% of patients had recurrence at 1 year

time to first healing was mean 76 days, 95% CI 39-98 days

fistula healing was associated with
fistula tract length ≤ 4 cm (HR 0.74, 95% CI 0.56-0.96)

no evidence of Permacol expulsion or leakage (hazard ratio [HR] 3.13, 95% CI 1.6-6.8)

failure to heal associated with presence of anal abscess (HR 4.2, 95% CI 1.3-26.5)

73% of patients were satisfied or very satisfied with procedure

adverse events reported in 29% of patients; 4 patients had serious adverse events such as new anal fistula, anal abscess, procedural pain, and complex regional pain syndrome

Reference - MASERATI100 trial (Colorectal Dis 2017 May 11 early online)

Autologous Stem Cell Injection
自體幹細胞注射

autologous stem cell injection into anal fistula has been reported to have healing rates between 35%-90%⁴
據報導，將自體幹細胞注射到肛瘺中的癒合率在 35%-90% ^{之間 4}
STUDY SUMMARY 研究總結
autologous adipose-derived stem cell injection may not improve healing of fistula tracts in patients with complex fistula
自體脂肪來源幹細胞注射可能無法改善複雜性瘺管患者的瘺管癒合
RANDOMIZED TRIAL: Dis Colon Rectum 2012 Jul;55(7):762
隨機試驗： Dis 結腸直腸 2012 年 7 月;55（7）：762
based on randomized trial without blinding of surgeons

200 adults with complex anal fistula had closure of internal tract opening then were randomized to 1 of 3 following groups with follow-up for 1 year
20 million adipose-derived stem cells injection

20 million stem cells injection plus fibrin glue

fibrin glue injection

if fistula was not healed at 3 months, second injection was administered (40 million stem cells if in a stem cell group) and second injection given to 113 patients

outcome assessors were blind to treatment group, and healing was defined as external opening re-epithelization and absence of collection > 2 cm by magnetic resonance imaging

at 6-6.5 months follow-up, healing in
39% with stem cells only (no significant difference among groups)

43.3% with stem cell plus fibrin glue

37.3% with fibrin glue plus placebo

at 1 year follow-up, healing in
57% with stem cells only (no significant difference among groups)

52.4% with stem cells plus fibrin glue

37.3% with fibrin glue plus saline

Reference - Dis Colon Rectum 2012 Jul;55(7):762
STUDY SUMMARY 研究總結
stem cell injection reported to have 60% complete healing rate at 1 year in patients with highly recurrent and complex fistulas
據報導，幹細胞注射在高度復發和複雜瘺管患者中 1 年完全癒合率為 60%

CASE SERIES: World J Gastroenterol 2015 Mar 21;21(11):3330
案例系列：世界胃腸病雜誌 2015 年 3 月 21 日;21（11）：3330
based on case series

10 adults (mean age 49 years; range 28-76 years) with highly recurrent and complex fistula and ≥ 3 failed surgical interventions (range 3-12 interventions) received autologous stem cells injection to fistula tracts and were followed for 1 year
3 patients had Crohn disease-associated fistula

8 patients received expanded adipose-derived stem cells, 1 patient received stromal vascular fraction, and 1 patient received allogeneic adipose derived stem cells

at 8 weeks post-injection
6 patients had complete cessation of suppuration (clinical response)

3 patients had partial decrease in suppuration (partial response)

at 1 year
6 patients had complete healing (external opening completely epithelialized)

no adverse events reported

Reference - World J Gastroenterol 2015 Mar 21;21(11):3330

Video-assisted Anal Fistula Treatment (VAAFT)
電視輔助肛瘺治療（VAAFT）

video-assisted anal fistula treatment (VAAFT)
電視輔助肛瘺治療（VAAFT）
- combines diagnostic and therapeutic procedures
  結合診斷和治療程式
- fistuloscope through external opening used to characterize main tract, internal opening, and potential secondary tracts or cavities
  通過外部開口的瘺管鏡，用於表徵主束、內開口和可能的繼發束或空腔
  - continuing to use fistuloscope, electrode used to annihilate and clean fistula
    繼續使用瘺管鏡，用於湮滅和清潔瘺管的電極
  - internal opening stapled or closed with advancement flap; fibrin glue may be used to reinforce closure
    內部開口用前進擋板裝訂或關閉;纖維蛋白膠可用於加固閉合
- reported success rates range between 58%-87%
  報告的成功率在 58%-87% 之間
- References - German S3 guideline for management of anal abscess and fistula (Langenbecks Arch Surg 2017 Mar;402(2):191)⁴, Dis Colon Rectum 2014 Mar;57(3):354
  參考資料 - 德國 S3 肛門膿腫和瘺管管理指南（Langenbecks Arch Surg 2017 年 3 月;402（2）：191）⁴， Dis 結腸直腸 2014 年 3 月;57（3）：354
- STUDY SUMMARY 研究總結
  video-assisted anal fistula treatment (VAAFT) reported to heal anal fistula in 84.6% of patients with complex fistula-in ano
  據報導，電視輔助肛瘺治療（VAAFT）可治癒 84.6% 的複雜瘺管 ANO 患者的肛瘺
  UNCONTROLLED TRIAL: Med Sci Monit 2017 Apr 30;23:2065
  非對照試驗：Med Sci Monit 2017 年 4 月 30 日;23：2065
  Gastrointestinal_Disordersvideo-assisted anal fistula treatment (VAAFT) reported to heal anal fistula in 84.6% of patients with complex fistula-in ano (Med Sci Monit 2017 Apr 30)07/12/2017 02:55:00 PM28456815
  based on uncontroled trial
  
  52 patients with complex anal fistula had VAAFT
  37 patients had high-transsphincteric fistulas, 8 had suprasphincteric fistulas, 5 had extrasphincteric fistulas, and 2 had horseshoe fistulas
  
  1 patient had Crohn disease
  
  15 patients had multiple tracts
  
  VAAFT equipment consists of fistuloscope, obturator, unipolar electrode, fistula probe, endobrush, forceps, and di-wing anoscope
  
  fistula tracts underwent fulguration from interior to exterior under direct vision, and necrotic debris removed, then interior opening closed with stapler or suturing, and fibrin glue
  
  complications included postoperative bleeding in 3 patients and perianal sepsis in 3 patients
  
  complete healing in 44 (84.6%) at 9 months follow-up
  
  no fecal incontinence reported
  
  Reference - Med Sci Monit 2017 Apr 30;23:2065
- VAFFT reported to heal anal fistula in 84% in case series of 82 patients with low (61 patients) and high (21 patients) fistula in ano (JSLS 2014 Jul)
  據報導，在 82 名低位（61 名患者）和高位（21 名患者）肛瘺患者的病例系列中，VAFFT 治癒了 84%的肛瘺（JSLS 2014 年 7 月）

Endoscopic Clips 內窺鏡夾

over-the-scope clip (OTSC) (also called bear-claw clips)⁴
超範圍夾（OTSC）（也稱為熊爪夾）⁴
- reported success rates range from 12%-90%
  報告的成功率為 12%-90%
- German S3 guideline note that over-the-scope clip (OTSC) closure may not have any distinct clear advantage over other established techniques (German S3 Grade 0, Level 4, Strong consensus)⁴
  德國 S3 指南指出，與其他已建立的技術（德國 S3 0 級，4 級，強烈共識）相比，超範圍夾（OTSC）閉合可能沒有任何明顯的明顯優勢 ⁴
inconsistent evidence for efficacy of bear-claw clip to close complex and high anal fistulas
熊爪夾閉合複雜和高位肛瘺療效的證據不一致
- STUDY SUMMARY 研究總結
  nitinol bear-claw closure clip reported to heal 59% of high and complex anal fistula
  據報導，鎳鈦合金熊爪閉合夾可治癒 59% 的高位複雜肛瘺
  
  CASE SERIES: Minim Invasive Ther Allied Technol 2017 Aug;26(4):227
  案例系列：最小侵入性 Ther Allied Technol 2017 年 8 月;26（4）：227
  based on retrospective case series
  
  22 adults (mean age 53 years, 3 female) with high or complex anal fistula received excision and/or seton and nitinol bear-claw clip (Clip OVESCO) closure, and were followed for mean of 3 years (range 19 months to 4 years)
  
  20 fistulae were transsphincteric (of these, 13 were at the linea dentata, 4 were under the linea dentata, and 2 were above the linea dentata), 1 fistula was anovaginal and at the linea dentata, and 1 fistula was intersphincteric and above the linea dentata
  
  mean duration of hospitalization post-surgery was 4 days (range 2-9 days)
  
  no intraoperative complications reported; no incontinence reported
  
  outcomes
  nitinol bear-claw clip was removed at mean 5 months after placement (range 3-12 months) (removal occurred with patient agreement, closed external fistula tract, and missing clinical symptoms, secretion, or abscess); 3 patients refused clip removal and reported no discomfort
  
  complete healing in 13 patients (59%)
  
  clinical re-occurrence in 9 patients (41%) secretion
  mean time to recurrence was 7 months (range 3-11 months)
  
  8 patients had re-operation, of these 1 had colostomy created
  
  5 patients had definitive healing post-recurrence, of these 3 received anal flap intervention
  
  Reference - Minim Invasive Ther Allied Technol 2017 Aug;26(4):227
- STUDY SUMMARY 研究總結
  nitinol bear-claw closure clip reported to heal only 18% of transsphincteric anal fistulas
  據報導，鎳鈦合金熊爪閉合夾僅能治癒 18% 的經括約肌肛瘺
  CASE SERIES: Int J Colorectal Dis 2015 May;30(5):621
  病例系列：國際結直腸疾病雜誌 2015 年 5 月;30（5）：621
  based on retrospective case series
  
  17 patients (median aged 42 yeas) with transsphincteric anal fistulas, as follows, were treated with bear claw clip (Clip OVESCO) closure and had median follow-up of 4 months
  
  all patients had single tract fistulas without inflammation at time of clip closure
  high fistulas (including 4 recto-vaginal fistulas) in 12 patients
  
  lower fistulas (with 3 recto-vaginal fistulas) in 5 patients
  
  Crohn's fistulas in 6 patients
  
  outcomes
  failure to heal fistula reported in 15 (88%)
  
  new abscess formation in 9 (53%)
  
  clip migration in 11 (65%) after median 10 days follow-up
  
  Reference - Int J Colorectal Dis 2015 May;30(5):621

Laser Ablation and Electrocautery
鐳射消融和電烙術

laser ablation with or without internal opening closure^3
,4
激光消融術（帶或不帶內開口閉合）^3,4
- radial fiber and laser diode at 1,470 nm wavelength placed through tract
  1,470 nm 波長的徑向光纖和半導體鐳射管穿過束
- this causes tract shrinkage around fiber
  這會導致纖維周圍的束收縮
- endorectal advancement flap may be added to close internal opening
  可添加直腸內前移皮瓣以關閉內部開口
- STUDY SUMMARY 研究總結
  laser ablation (FiLaC) of crypt gland and fistula tract reported to heal 64% of anal fistulas, without need for second procedure, in patients with cryptoglandular or Crohn-related fistula in ano
  據報導，隱匿腺或克羅恩相關瘺管患者的隱腺和瘺管鐳射消融（FiLaC）可治癒 64% 的肛瘺，無需二次手術
  
  UNCONTROLLED TRIAL: Tech Coloproctol 2017 Apr;21(4):269
  非對照試驗：Tech Coloproctol 2017 年 4 月;21（4）：269
  Gastrointestinal_Disorderslaser ablation (FiLaC) of crypt gland and fistula tract reported to heal 64% of anal fistulas, without need for second procedure, in patients with cryptoglandular or Crohn-related fistula-in-ano (Tech Coloproctol 2017 Apr)07/18/2017 02:44:00 PM28271331
  based on uncontrolled trial
  
  117 patients (median age 46 years, 30% female) with anal fistula (88.9% cryptoglandular and 11.1% Crohn-related) received fistula excision, laser probe ablation, and internal closure with mucosal advancement or anodermal flap and followed for median 2 years (range 6 months to 5 years)
  
  permanent healing defined as ≥ 1 year with absence of symptoms and no evidence of recurrence or persistence clinically, proctoscopically, or endosonographically; and no additional intervention required
  
  primary success (healing after initial laser treatment) reported in 75 patients (64%)
  
  secondary healing (healing at end of study, including fistulas that needed second operation of surgeon's choice) reported in 103 patients (88%)
  
  Parks Type 1 classification of fistula associated with increased rate of success (risk ratio 1.63, 95% CI 1.39-1.93) compared to Type II
  
  no significant difference comparing healing rates of patients with cryptoglandular vs. Crohn-associated fistula
  
  7 patients reported minor soiling (3 after primary procedure, and 4 after repeat fistula surgery); 11 patients had persistent fistula at follow-up
  
  Reference - Tech Coloproctol 2017 Apr;21(4):269
- STUDY SUMMARY 研究總結
  laser ablation of fistula tract reported to have 71% success rate
  據報導，鐳射消融瘺管的成功率為 71%
  
  CASE SERIES: Tech Coloproctol 2015 Aug;19(8):449
  案例系列：Tech Coloproctol 2015 年 8 月;19（8）：449
  based on retrospective case series
  
  45 patients (mean age 46 years, 46.7% male) with anal fistula received fistula tract laser closure and were followed for median 2 years (range 6-46 months)
  
  fistula was intersphincteric in 7 patients, low transsphincteric in 7 patients, mid-transsphincteric in 19 patients, high transsphincteric in 10 patients, and suprasphincteric in 2 patients
  
  78% of patients had history of prior surgery for anal fistula
  
  outcomes
  primary healing in 32 patients (71%), with median healing time 5 weeks (range 3-8 weeks)
  
  of 13 patients with treatment failure, 2 patients had early failure (persistent symptoms)
  
  median intensity of postoperative pain was 3 on visual analogue scale of 1-10 during first week
  
  no incontinence reported
  
  Reference - Tech Coloproctol 2015 Aug;19(8):449
STUDY SUMMARY 研究總結
transanal opening of intersphincteric space (TROPIS) reported to heal complex fistula in ano in 72% of patients
據報導，經肛門括約肌間隙開放（TROPIS）可治癒 72% 患者的 ANO 複雜瘺管
UNCONTROLLED TRIAL: Int J Surg 2017 Apr;40:130
非對照試驗：Int J Surg 2017 年 4 月;40：130
based on uncontrolled trial

61 patients with high complex intersphincteric anal fistula had transanal opening of intersphincteric space (TROPIS) procedure involving electrocautery to create transanal opening of fistula tract at mucosal and internal sphincter level, followed by curettage of tracts

curetted tracts cleaned twice daily with swab mounted on artery forceps by a trained nurse, medical attendant, or relative (tube-in-tract technique)

44 (72%) cured with complete healing, 9 (15%) had failure of treatment, 9 (15%) excluded from analysis due to infection with tuberculosis, incomplete procedure, or loss to follow-up

no significant change in incontinence

Reference - Int J Surg 2017 Apr;40:130
STUDY SUMMARY 研究總結
proximal cauterization around the internal opening, emptying regularly of fistula tracts and curettage of tracts (PERFACT) reported to heal supralevator fistula in ano (SLF) in 65% of patients
據報導，內部開口周圍的近端燒灼、定期排空瘺管和刮宮（PERFACT）可治癒 65% 患者的 ANO 抬上瘺（SLF）
UNCONTROLLED TRIAL: World J Gastrointest Surg 2016 Apr 27;8(4):326
非對照試驗：世界 J Gastrointest 外科雜誌 2016 年 4 月 27 日;8（4）：326
based on uncontroled trial

17 patients with patients with cryptoglandular supralevator fistula in ano (SLF) (Park's type 3) and/or supralevator abscess had electrocautery around the internal fistula opening, and curettage of tracts via external opening

curetted tracts cleaned twice daily with swab mounted on artery forceps by a trained nurse, medical attendant, or relative (tube-in-tract technique)

11 (65%) cured, 4 (24%) had failure of treatment, 2 unable to comply with therapy

2 patients with failure repeated procedure with 1 eventually cured

no significant change in incontinence

Reference - World J Gastrointest Surg 2016 Apr 27;8(4):326

video vignette of tube-in-tract technique as an alternative to loose draining seton for complex fistula in ano can be found in Colorectal Dis 2016 Jan;18(1):107

Seton Placement Seton 放置

seton placement^1
,2
,4
設置位置 ^1,2,4
- most typically used with high trans-sphincteric fistula
  最常用於高位經括約肌瘺
- may be first step in treating complex fistulas
  可能是治療複雜瘺管的第一步
- seton consists of suture, rubber band, or Silastic vessel loop placed through tract to encourage perisphincter fibrosis through foreign body inflammatory response
  掛線由縫合線、橡皮筋或穿過束放置的矽橡膠血管環組成，以通過異物炎症反應促進括約肌周圍纖維化
loose seton 鬆散的 Seton
- may promote drainage to decrease inflammation, establish well-formed tract, and avoid recurrent perineal infection; can be used long-term (very rarely) or removed after drainage to allow for spontaneous fistula healing
  可促進引流以減少炎症，建立形成良好的腸道，並避免復發性會陰感染;可以長期使用（非常罕見）或在引流後移除，以實現瘺管自發癒合
- typically staged process, with initial seton used to control infection followed by secondary procedure, such as ligation of the intersphincteric fistula tract (LIFT) or another method, a few weeks later
  通常為分期過程，初始掛線用於控制感染，然後是繼發性手術，例如括約肌間瘺束結紮（LIFT）或其他方法，幾周后
- reported 33%-100% success rate, and 0%-62% impaired continence rate
  報告的成功率為 33%-100%，失禁率為 0%-62%
cutting seton^1
,2
,3
,4
切割掛件 ^1,2,3,4
- progressive tightening produces gradual fistulotomy with tract scarring over few weeks duration without secondary procedure
  進行性收緊可在數周內產生逐漸的瘺管切開術，並在幾周內形成瘢痕形成，無需二次手術
- goal is to resolve fistula without allowing sphincter muscle to spring apart, avoiding incontinence
  目標是在不影響括約肌彈開的情況下解決瘺管，避免尿失禁
- may be useful for transsphincteric fistula
  可能有助於經括約肌瘺
- reported success rates 80%-100%
  報告的成功率 80%-100%
- may be associated with high incontinence rate (reported rate 0%-92%)
  可能與高尿失禁率有關（報告率 0%-92%）
- German S3 guideline does not recommend use of cutting seton due to potentially high incontinence rate (German S3 Grade B, Level 2a), although the American Society of Colon and Rectal Surgeons (ASCRS) notes cutting seton may be used with caution (ASCRS Grade 2B)
  德國 S3 指南不建議使用切割掛線，因為尿失禁率可能很高（德國 S3 B 級，2a 級），儘管美國結腸直腸外科醫生協會（ASCRS）指出可以謹慎使用切割掛線（ASCRS 2B 級）
- STUDY SUMMARY 研究總結
  modified Hanley procedure with posterior midline cutting seton placement reported to resolve complex horseshoe fistula in most patients
  據報導，改良的 Hanley 手術與後中線切割掛線放置可解決大多數患者的複雜馬蹄形瘺
  CASE SERIES: Tech Coloproctol 2009 Dec;13(4):301
  案例系列：Tech Coloproctol 2009 年 12 月;13（4）：301
  based on retrospective case series
  
  23 patients (mean age 50.3 years) with posterior high transpheric horseshoe fistula with median symptom duration of 2 years were treated with modified Hanley procedure and posterior mid-line cutting seton placement between 2003-2008 and were followed for mean 15 months (range 2-38 months)
  
  mean number of setons received was 3 (range 2-7 setons); cutting setons were tightened monthly for a mean of 5 times (after last drain removal)
  
  21 patients (91.3%) had complete fistula resolution at mean 8 months (range 2-20 months), of these
  4 patients required surgical re-intervention
  
  3 patients with colostomies at baseline achieved colostomy closing
  
  19 patients regained full functionality and were able to return to work within 4 weeks of surgery
  
  2 patients had persistent or recurrent fistula
  
  no patients reported incontinence
  
  Reference - Tech Coloproctol 2009 Dec;13(4):301
STUDY SUMMARY 研究總結
external anal sphincter-sparing seton shortens time to complete healing compared to standard drainage seton in adults with complex anal fistula
與標準引流掛線相比，保留肛門外括約肌的掛線縮短了成人複雜肛瘺完成癒合的時間
RANDOMIZED TRIAL: Dis Colon Rectum 2019 Aug;62(8):980
隨機試驗： Dis Colon Rectum 2019 年 8 月;62（8）：980
Gastrointestinal_Disorders Surgery_and_Proceduresexternal anal sphincter-sparing seton shortens time to complete healing compared to standard drainage seton in adults with complex anal fistula (Dis Colon Rectum 2019 Aug)07/25/2019 12:35:37 PM
based on randomized trial with limited generalizability

62 adults (mean age 43 years, 93% men) with complex anal fistula were randomized to external anal sphincter-sparing seton using rerouting of fistula tract around internal anal sphincter vs. standard drainage seton and followed for 12 months

60 patients (97%) completed follow-up and were included in analysis

postoperative pain was measured on visual analog scale (range 0-10 points, with higher scores indicating more pain)

trial was performed at single center limiting generalizability

comparing external anal sphincter-sparing seton vs. conventional drainage seton
mean time to complete healing 46 days vs. 103 days (p < 0.0001)

need for second-stage fistulotomy in 7% vs. 100% (p < 0.0001, NNT 1)

persistent or recurrent anal fistula in 3% vs. 13% (not significant)

mean operation time 43.8 minutes vs. 29.8 minutes (p < 0.0001)

mean postoperative pain score
5.3 points vs. 8.1 points (p < 0.0001) at 24 hours

3.3 points vs. 5.5 points (p < 0.0001) at 7 days

complications including fecal incontinence in 7% vs. 17% (not significant)

no significant difference in physical, social, or sexual activity after treatment

Reference - Dis Colon Rectum 2019 Aug;62(8):980
STUDY SUMMARY 研究總結
fibrin glue injection appears less effective than seton therapy for healing medium or high anal fistulas, but may have lower rate of incontinence
纖維蛋白膠注射在治癒中度或高度肛瘺方面似乎不如 Seton 療法有效，但失禁的發生率可能較低
RANDOMIZED TRIAL: Colorectal Dis 2011 Jan;13(1):82
隨機試驗：結直腸疾病 2011 年 1 月;13（1）：82
based on small randomized trial

62 patients with medium or high transsphincteric anal fistula randomized to fibrin glue vs. seton treatment and followed for 1 year; seton treatment arm had only 24 patients

comparing fibrin glue vs. seton therapy, fibrin glue associated with
reduced healing rate (fistula cured in 39.5% vs. 87.5%, p = 0.0007)

decreased incontinence (p = 0.0001)

decreased hospital stay (p < 0.0001)

increased resting anal pressure (p = 0.003)

50% of patients retreated with fibrin glue after initial failure achieved fistula healing

Reference - Colorectal Dis 2011 Jan;13(1):82
hybrid setons 混合動力 SETONS
- hybrid setons may be created from elastic material, such as surgical glove, and associated with less tension than traditional cutting seton)
  混合 Seton 可以由彈性材料製成，例如手術手套，並且比傳統切割掛線的張力更小）
- modified Hanley procedure with hybrid elastic seton reported resolve complex fistulas
  據報導，使用混合彈性掛線的改良 Hanley 手術可解決複雜瘺管
  - based on 2 retrospective case series
    基於2個回顧性病例系列
  - 128 patients (25.8% female) with high anal fistula (37 with anterior transsphincteric fistulas [high and/or transsphincteric in women]) received modified Hanley procedure with hybrid seton and were followed for median 31 months (range 1-5 years)
    128 例高位肛瘺患者（25.8% 為女性）（37 例為前經括約肌瘺 [女性高位和/或經括約肌]）接受了混合掛線的改良 Hanley 手術，並隨訪中位 31 個月（範圍 1-5 年）
    - 25 patients (19.5% had received 1-4 prior surgical interventions for fistula)
      25 例患者（19.5% 既往接受過 1-4 次瘺管手術干預）
    - postoperatively, mean visual analogue scale pain ratings were 3.23 on postoperative day 1 and 0.61 on postoperative day 7
      術后，術后第 1 天的平均視覺類比量表疼痛評分為 3.23，術后第 7 天為 0.61
    - complete healing achieved in 67 patients at 1 month and all patients at 3 months
      67 名患者在 1 個月時完全癒合，所有患者在 3 個月時完全癒合
      - mean time for hybrid seton to cut through sphincter and drop was 18 days (range 11-30 days)
        Hybrid Seton 切開括約肌並滴落的平均時間為 18 天（範圍 11-30 天）
      - 2 patients had recurrent fistula (1 at 6 months and 1 at 1 year)
        2 例患者有復發性瘺管（1 例在 6 個月時，1 例在 1 歲時）
    - mean scores on Fecal Incontinence Quality of Life Index were significantly improved from baseline on all subscales at 3 months and 1 year
      在 3 個月和 1 年時，所有分量表的大便失禁生活質量指數平均得分均較基線顯著提高
    - Reference - Tech Coloproctol 2014 Feb;18(2):187
      參考資料 - Tech Coloproctol 2014 年 2 月;18（2）：187
  - 21 patients (median age 48 years, 23.8% female) with horseshoe fistula received modified Hanley procedure with hybrid seton created from surgical glove and followed for mean 20 months (range 1-6 years)
    21 例馬蹄形瘺患者（中位年齡 48 歲，23.8% 為女性）接受了改良的 Hanley 手術，由手術手套製成混合掛線，平均隨訪 20 個月（範圍 1-6 年）
    - all patients were discharged on first post-operative day, and no patients required narcotic analgesics after discharge
      所有患者均在術后第 1 天出院，出院后無患者需要麻醉鎮痛藥
    - all patients had complete healing, with mean time to healing of 8 weeks (range 5-20 weeks)
      所有患者均完全癒合，平均癒合時間為 8 周（範圍 5-20 周）
      - hybrid seton cut through sphincter and dropped at mean 40 days (range 25-120 days)
        Hybrid Seton 切開括約肌，平均 40 天掉落（範圍 25-120 天）
      - 2 patients had loose seton under anoderm at 3 months (both were easily removed)
        2 例患者在 3 個月時肛門下出現鬆散的掛線（均易於去除）
      - return to regular work activity occurred at mean 3.5 weeks
        平均3.5周後恢復正常工作
      - 1 patient had recurrent fistula at 4 months, and 1 patient had worsening of baseline continence
        1 例患者在 4 個月時出現復發性瘺管，1 例患者基線尿失禁惡化
    - Reference - Tech Coloproctol 2013 Aug;17(4):411
      參考資料 - Tech Coloproctol 2013 年 8 月;17（4）：411

Fistula Excision With Direct Sphincter Reconstruction
瘺管切除術直接括約肌重建術

fistulotomy (without sphincter reconstruction) generally reserved for simple anal fistulas¹
瘺管切開術（無括約肌重建）通常用於單純性肛瘺 ¹
failure of fistulotomy associated with complex fistulas and failure to identify the internal opening¹
與複雜瘺管相關的瘺管切開術失敗和未能識別內部開口 ¹
fistula excision with direct sphincter reconstruction might be an option for management of complex fistulas, but with limited evidence currently available (German S3 Grade A, Level 1b)⁴
瘺管切除術聯合直接括約肌重建可能是治療複雜瘺管的一種選擇，但目前可用的證據有限（德國 S3 A 級，1b 級）⁴
- consists of primary readaptation of divided sphincter apparatus after complete excision of fistula and associated inflammatory tissue
  包括在完全切除瘺管和相關炎症組織后對分裂的括約肌器官進行一期再適應
- reported success rates are 54%-97%
  報告的成功率為 54%-97%
- reported incontinence rates are 4%-32%
  報告的失禁率為 4%-32%
- wound dehiscence after division (particularly in high fistulas) associated with high risk of incontinence
  分裂後傷口裂開（尤其是在高位瘺管中）與尿失禁的高風險相關
STUDY SUMMARY 研究總結
fistulotomy with sphincter reconstruction (sphincteroplasty) may yield similar continence and successful closure rate as advancement flaps in patients with high transsphincteric or suprasphincteric anal fistulas
對於高位經括約肌或括約肌上痔瘺患者，瘺管切開術聯合括約肌重建術（括約肌成形術）可能產生與前移皮瓣相似的尿失禁和成功閉合率
RANDOMIZED TRIAL: Am J Surg 2006 Jul;192(1):34
隨機試驗： Am J Surg 2006 年 7 月;192（1）：34
based on small randomized trial

30 patients with anal fistulas with high transsphincteric and suprasphincteric tracks randomized to 1 of 2 following procedures
closure with advancement flaps including mucosa, submucosa, and full thickness of muscle

fistulotomy with sphincter reconstruction (sphincteroplasty)

patients followed postoperatively for mean of 36 months

recurrence of anal fistula in 7.4% with advancement flaps vs. 7.2% with fistulotomy plus sphincteroplasty (not significant)

no significant difference in change in continence comparing advancement flaps vs. fistulotomy with sphincteroplasty

Reference - Am J Surg 2006 Jul;192(1):34
STUDY SUMMARY 研究總結
fistulotomy and immediate sphincteroplasty reported to have 84% healing rate in adults with complex anal fistulas of cryptoglandular origin at median 8-year follow-up
據報導，在中位 8 年隨訪中，瘺管切開術和即刻括約肌成形術在隱腺起源的複雜肛瘺成人中的癒合率為 84%
COHORT STUDY: Dis Colon Rectum 2021 Nov 1;64(11):1374
佇列研究：Dis 結腸直腸 2021 年 11 月 1 日;64（11）：1374
based on noncomparative data in prospective cohort study

107 adults (mean age 48 years, 68% male) having fistulotomy and immediate sphincteroplasty for complex anal fistula of cryptoglandular origin were followed for median 8 years
65.4% had primary fistulas and 34.6% had recurrent fistulas

34.6% had high fistulas (suprasphincteric and high transsphincteric) involving > 50% of external sphincter and 65.4% had nonhigh fistulas (medium transsphincteric) involving < 50% of external sphincter

mean fistula symptom duration was 12.8 months

all patients received postoperative IV metronidazole for 3 days, followed by oral metronidazole for 4 days

healing was defined as absence of purulent drainage through fistula and healing or closure of external and internal openings without symptoms

healing rates after fistulotomy and immediate sphincteroplasty
84.1% overall

82.9% in patients with primary fistula

86.5% in patients with recurrent fistula

83.8% in patients with high fistula tract

84.3% in patients with nonhigh fistula tract

36.5% had improved continence and 11.2% showed deterioration in continence

Reference - Dis Colon Rectum 2021 Nov 1;64(11):1374
STUDY SUMMARY 研究總結
fistulotomy or fistulectomy and primary sphincteroplasty reported to have 85.7%-100% success rate for healing of complex anal fistulas
據報導，瘺管切開術或瘺管切除術和初次括約肌成形術對複雜肛瘺的癒合成功率為 85.7%-100%
SYSTEMATIC REVIEW: Tech Coloproctol 2015 Jul;19(7):391
系統評價： Tech Coloproctol 2015 年 7 月;19（7）：391
based on systematic review of mostly observational studies

systematic review of 14 studies evaluating fistulotomy or fistulectomy and primary sphincteroplasty in 666 patients with complex anal fistulas of cryptoglandular origin

weighted mean duration of follow-up was 29 months (range 12-81 months)

fistula outcomes (weighted means or rates)
mean success rate 93.2% (range 85.7%-100%) in analysis of 14 studies

mean time to recurrence 8.9 months (range 1.5-20 months) in analysis of 8 studies reporting this outcome

rate of wound dehiscence (postoperative complication associated with risk of incontinence) reported 2.2% (range 0%-8.3%)

in 7 studies with wound suturing, mean healing rate without dehiscence was 68.9% (range 28.6%-100%)

postoperative continence outcomes (weighted means or rates)
major fecal incontinence rate of 2.7% (defined as incontinence to liquid or solid stools); baseline value was 1.1%

minor fecal incontinence of 15.4% (defined as incontinence to gas and/or post-defecation soiling); baseline value was 8.6%

overall rate of deteriorated continence from baseline full continence was 12.4% (mainly minor incontinence)

other complications reported as minor in studies included proctalgia or defecation disorders, urinary retention, fecal impaction, anal abscess, deformity, and wound complications

Reference - Tech Coloproctol 2015 Jul;19(7):391

Colostomy 結腸造口術

colostomy²
結腸造口術 ²
- defunctioning bowel and bringing out proximal colon as colostomy diversion considered last resort for nonhealing anal fistula
  腸功能失調和引出近端結腸作為結腸造口分流被認為是不癒合的肛瘺的最後手段
- rarely, colostomy may be required if perianal infection is difficult to control and multiple tracts exist
  極少數情況下，如果肛周感染難以控制且存在多個腸道，則可能需要結腸造口術
- diverts bowel contents to provide optimum environment for infection resolution
  轉移腸內容物，為感染消退提供最佳環境
- once fistulas are resolved, colostomy may be reversed in some patients
  一旦瘺管得到解決，一些患者的結腸造口術可能會逆轉

Vacuum Therapy With Endofistular Polyurethane Sponge
使用瘢下聚氨酯海綿進行真空療法

endofistular vacuum therapy for anal fistulas utilizes vacuum to remove endofistular pseudoepithelium and induce granulation in fistula tract (Dis Colon Rectum 2018 Dec;61(12):1435)
肛瘺的皃柱外真空療法利用真空去除瘺管外假上皮並誘導瘺管肉芽（Dis Colon Rectum 2018 年 12 月;61（12）：1435）
STUDY SUMMARY 研究總結
endofistular vacuum therapy using polyurethane sponge reported to have 86% healing rate for complicated anal fistulas > 4 cm
據報導，使用聚氨酯海綿的瘿外真空療法對 4 cm >複雜性肛瘺的癒合率為 86%
CASE SERIES: Dis Colon Rectum 2018 Dec;61(12):1435
病例系列：Dis 結腸直腸 2018 年 12 月;61（12）：1435
based on case series

7 patients (median age 42 years) with complicated anal fistulas > 4 cm associated with Crohn disease or of cryptoglandular origin were treated with endofistular vacuum therapy using polyurethane sponge
fistula was initially curettaged and first endofistular vacuum sponge was positioned in fistula tract, followed by closing of inner fistula opening by suture and application of 125 mm Hg constant vacuum to sponge

sponge was changed 3-5 times after every 48-72 hours of constant vacuum therapy

median procedure time for device placement was 20 minutes

time from initial placement of first sponge to final removal of last sponge ranged from 10-14 days

at median follow-up 9 months, 6 patients (86%) had complete healing of fistula tract

1 patient had recurrence of cryptoglandular fistula within 3 months and was treated with surgical fistulectomy

no intraprocedural adverse events or dislocation of sponge reported

Reference - Dis Colon Rectum 2018 Dec;61(12):1435

Comparative Efficacy 比較功效

STUDY SUMMARY 研究總結
limited evidence to evaluate superiority of any single procedure for closure of high perianal fistulas
評估任何單一手術閉合肛周高位瘺管的優越性的證據有限
SYSTEMATIC REVIEW: Int J Colorectal Dis 2015 May;30(5):583
系統評價：國際結直腸疾病雜誌 2015 年 5 月;30（5）：583
based on systematic review limited by clinical and statistical heterogeneity

systematic review of 14 randomized trials prior to 2013 November evaluating surgical techniques to close high cryptoglandular perianal fistulas

compared to mucosa advancement flap alone, addition of fibrin glue to advancement flap associated with higher recurrence rate in 1 trial with 58 patients (p < 0.05) (summarized)

compared to mucosa advancement flap, rectal wall flap associated with lower recurrence but higher incontinence in 1 trial with 40 patients (p < 0.05)

compared to fibrin glue, seton use (loose or cutting) associated with decreased recurrence (p < 0.05), but increased incontinence in 1 trial with 64 patients ((summarized)

no significant difference in recurrence in the following comparisons
fistula plug vs. mucosa advancement flap in 3 high-quality trials with 182 total patients, results limited by statistical heterogeneity

ligation of intersphincteric fistula tract (LIFT) vs. mucosa advancement flap in 1 trial with 39 patients (summarized)

addition of gentamicin collagen sponge placement with mucosa advancement flap vs.. mucosa advancement flap alone in 1 trial with 83 patients

autologous stem cells vs. autologous stem cells and fibrin glue vs. fibrin glue and placebo in 1 trial with 183 patients (all fistulas curetted and closed prior to injection)

mucosa advancement flap vs. fistulotomy plus sphincter reconstruction in 1 trial with 55 patients

fibrin glue plus antibiotics vs. fibrin glue plus suture closure vs. fibrin glue plus antibiotics plus suture closure in 1 trial with 68 patients

sphincter-preserving seton (involving mucosa advancement flap then seton treatment) vs, conventional seton in 1 trial with 34 patients

Kshaarasootra (Ayurvedic) seton vs. fistulectomy in 1 trial with 73 patients

unreliable, unevaluable data found in comparison of island flap anoplasty vs. seton treatment in 1 trial with 4 patients

Reference - Int J Colorectal Dis 2015 May;30(5):583

Evidence Synopsis 證據概要

STUDY SUMMARY 研究總結
LIFT procedure may yield similar healing rates for high transsphincteric fistulas as mucosal advancement flap, and LIFT might preserve continence more effectively with less inpatient care
對於高位經括約肌瘺，LIFT 手術可能產生與粘膜推進皮瓣相似的癒合率，並且 LIFT 可能會以較少的住院護理更有效地保持節制

RANDOMIZED TRIAL: Dis Colon Rectum 2014 Oct;57(10):1202
隨機試驗： Dis Colon Rectum 2014 年 10 月;57（10）：1202
based on randomized trial without blinding

70 patients aged ≥ 18 years with high transsphincteric cryptoglandular anal fistulas were randomized to ligation of intersphincteric fistula track (LIFT) vs. mucosal advancement flap (MAF)
LIFT performed as outpatient or with 1 day inpatient, and patients allowed full diet postoperatively

MAF required inpatient admission for 2 days with nothing by mouth for first post-op day

all patients received antibiotics for 1 week post-op

comparing LIFT vs. MAF
complete healing of fistula in 94.2% vs. 91.4% (not significant)

mean healing time 26.6 vs. 38.1 days (p = 0.0004)

recurrent fistula in 21.2% vs. 28.1% (not significant)

at 4 weeks follow-up, worsened continence in 0% vs. 14% (p = 0.054)

Reference - Dis Colon Rectum 2014 Oct;57(10):1202
STUDY SUMMARY 研究總結
LIFT associated with similar healing and recurrence as advancement flap procedure, and may allow for faster return to normal activities
LIFT 與推進皮瓣手術類似的癒合和復發相關，並且可能允許更快地恢復正常活動
RANDOMIZED TRIAL: Am J Surg 2012 Sep;204(3):283
隨機試驗：Am J Surg 2012 年 9 月;204（3）：283
based on small randomized trial

39 patients with complex fistula in ano randomized to LIFT vs. anorectal advancement flap (ARAF)

all patients had draining seton prior to LIFT or ARAF

comparing LIFT vs. ARAF
mean time of procedure 10 vs. 42.5 minutes (p < 0.05)

healing by 1 month in 68% vs. 85% (not significant)

recurrence in 8% vs. 7% (not significant)

no differences in continence

time to return to normal activities 1 week vs. 2 weeks (p = 0.016)

complication of secondary bleed in 4% with LIFT vs. no complications with ARAF

Reference - Am J Surg 2012 Sep;204(3):283

STUDY SUMMARY 研究總結
Surgisis fistula plug and surgeon's surgical preference may have similar fecal incontinence quality of life (FIQoL) scores and clinical healing rates at 12 months, but fistula plug may be associated with increased rates of complications and reinterventions at 6 weeks in adults with clinically diagnosed cryptoglandular transsphincteric fistula in ano
手術瘺管栓和外科醫生的手術偏好在 12 個月時可能具有相似的大便失禁生活品質（FIQoL）評分和臨床癒合率，但瘺管栓可能與臨床診斷為隱腺經括約肌瘺的成人在 6 周時併發症和再干預率增加有關
RANDOMIZED TRIAL: Ann Surg 2020 Jun 9 early online
隨機試驗： Ann Surg 2020 Jun 9 提前在線
Surgery_and_ProceduresSurgisis fistula plug and surgeon's surgical preference may have similar FIQoL scores and clinical healing rates at 12 months, but fistula plug may be associated with increased rates of complications and reinterventions at 6 weeks in adults with clinically diagnosed cryptoglandular transsphincteric fistula in ano (Ann Surg 2020 Jun 9 early online)10/19/2020 10:43:25 AM
based on randomized trial with baseline differences

304 adults (mean age 45 years, 55% men) with clinically diagnosed cryptoglandular transsphincteric fistula in ano (involving ≥ one-third of external anal sphincter) were randomized to anal fistula plug vs. surgeon’s surgical preference and followed for 12 months
fistula plug procedure consisted of removing draining seton, gentle curettage of tract, and inserting rehydrated 4 mm or 7 mm Biodesign Surgisis plug (all surgeons inserted ≥ 3 plugs before trial start)

surgeon’s preference included advancement flap, cutting seton, fistulotomy, and LIFT procedure

all patients had fistula with 1 internal opening, tract ≥ 2 cm in length, and treatment with draining seton for ≥ 6 weeks before randomization

magnetic resonance imaging confirmed transsphincteric fistula in 87% in fistula plug group and 90% in surgeon's preference group

FIQoL assessed by questionnaire evaluating lifestyle, coping, depression, and embarrassment (range 1-4, with higher scores indicating better quality of life)

protocol amended to reduce sample size from 500 to 300 patients due to slow recruitment (resulting in 69% power to detect small-to-moderate difference and 98% power to detect moderate difference)

96% completed 12-month follow-up, 100% were included in analysis of FIQoL

88.8% received allocated intervention in fistula plug group and 94% in surgeon's preference group

at baseline, comparing fistula plug group vs. surgeon's preference group (no p value reported)
previous fistula surgery in 42% vs. 48%

presence of extensions in 27% vs. 23%

intersphincteric extensions in 41% vs. 54%

FIQoL score 3.46 points vs. 3.34 points

comparing fistula plug vs. surgeon's preference
FIQoL lifestyle at 12 months 3.6 points vs. 3.54 points (adjusted mean difference 0.03 over 3 repeated measurements, 95% CI -0.1 to 0.15)

clinical fistula healing at 12 months in 54% vs. 55% (not significant)

rate of patients currently having complications at 6 weeks (bleeding, unexplained pain, and septic event) 35% vs. 18% (p = 0.002, NNH 5)

rate of patients currently having reinterventions at 6 weeks 21% vs. 12% (p = 0.03, NNH 11)

no significant differences in rates of patients currently having complications or reinterventions prior to discharge, or at 6 and 12 months

no significant differences over 12 months in subdomains of FIQoL scores or St. Marks Incontinence scores at 6 weeks and 6 and 12 months

in surgeon's preference group, clinical fistula healing at 12 months in 75% with fistulotomy, 64% with cutting seton, 53% with advancement flap, and 42% with LIFT procedure (no p values reported)

Reference - FIAT trial (Ann Surg 2020 Jun 9 early online)
STUDY SUMMARY 研究總結
anal fistula plug and mucosal advancement flap associated with similar functional outcome, quality of life, and recurrence rates in patients with high transsphincteric perianal fistula
經括約肌肛周瘺患者的肛瘺栓和粘膜前移皮瓣與相似的功能結局、生活品質和復發率相關
RANDOMIZED TRIAL: Dis Colon Rectum 2011 Apr;54(4):387
隨機試驗： Dis 結腸直腸 2011 年 4 月;54（4）：387
based on small randomized trial

60 adults with cryptoglandular high transsphincteric perianal fistula randomized to anal fistula plug (31 patients) vs. mucosal advancement flap (29 patients)

recurrence at 11 months in 71% with anal fistula plug vs. 52% with mucosal advancement flap (not significant)

no significant differences in postoperative quality of life, pain, soiling, or incontinence score

Reference - Dis Colon Rectum 2011 Apr;54(4):387
STUDY SUMMARY 研究總結
fibrin glue injection appears less effective than seton therapy for healing medium or high anal fistulas, but may have lower rate of incontinence
纖維蛋白膠注射在治癒中度或高度肛瘺方面似乎不如 Seton 療法有效，但失禁的發生率可能較低
RANDOMIZED TRIAL: Colorectal Dis 2011 Jan;13(1):82
隨機試驗：結直腸疾病 2011 年 1 月;13（1）：82
based on small randomized trial

62 patients with medium or high transsphincteric anal fistula randomized to fibrin glue vs. seton treatment and followed for 1 year; seton treatment arm had only 24 patients

comparing fibrin glue vs. seton therapy, fibrin glue associated with
reduced healing rate (fistula cured in 39.5% vs. 87.5%, p = 0.0007)

decreased incontinence (p = 0.0001)

decreased hospital stay (p < 0.0001)

increased resting anal pressure (p = 0.003)

50% of patients retreated with fibrin glue after initial failure achieved fistula healing

Reference - Colorectal Dis 2011 Jan;13(1):82

Crohn Disease-associated Fistula
克羅恩病相關瘺管

Approach to Remission Induction
誘導緩解的方法

medication is primary treatment for perianal fistulas in patients with Crohn disease ¹
藥物治療是克羅恩病 ¹ 患者肛周瘺的主要治療方法
surgery reserved for infection control and occasionally adjunct for cure¹
手術僅用於感染控制，偶爾輔助治療 ¹
- Crohn disease may result in proctectomy or permanent diversion in patients with severe disease
  克羅恩病可能導致重症患者進行直腸切除術或永久性改道術
- see also Surgical Management of Crohn Disease in Adults
  另見成人克羅恩病的手術治療
see also Induction of Remission in Crohn Disease in Adults and Management of Crohn Disease in Children for further recommendations, medication dosing, and safety considerations
另請參閱成人克羅恩病緩解的誘導和兒童克羅恩病的管理，以進一步推薦、藥物劑量和安全注意事項
American College of Gastroenterology (ACG) 2018 guidelines for perianal fistulizing Crohn disease in adults
美國胃腸病學會（ACG） 2018 年成人肛周瘺固定性克羅恩病指南
- drain abscesses surgically or percutaneously before initiating tumor necrosis factor inhibitors (anti-TNF therapy) in fistulizing Crohn disease (ACG Conditional recommendation, Very low-quality evidence)
  在瘺管性克羅恩病中開始使用腫瘤壞死因數抑製劑（抗 TNF 治療）之前，手術或經皮引流膿腫（ACG 條件推薦，極低質量證據）
- recommended options for fistulizing Crohn disease
  瘺管性克羅恩病的推薦選擇
  - infliximab is effective for perianal fistulizing disease (ACG Strong recommendation, Moderate-quality evidence)
    英夫利昔單抗對肛周瘺管疾病有效（ACG 強烈推薦，中等質量證據）
    - for perianal fistula, consider seton placement in addition to infliximab, as it is reported to increase infliximab efficacy (ACG Strong recommendation, Moderate quality evidence)
      對於肛周瘺，除了英夫利昔單抗外，還考慮放置 Seton，因為據報導它可以提高英夫利昔單抗的療效（ACG 強烈推薦，中等質量證據）
    - consider addition of antibiotics to increase efficacy of infliximab for perianal fistulas (ACG Strong recommendation, Moderate-quality evidence)
      考慮添加抗生素以提高英夫利昔單抗治療肛周瘺的療效（ACG 強烈推薦，中等質量證據）
    Image 1 of 1 圖片1 / 1
    Fistula treatment in Crohn disease
    克羅恩病的瘺管治療
    Enterocutaneous fistula and perineal fistula closure following treatment with infliximab.
    英夫利昔單抗治療后的腸皮瘺和會陰瘺閉合。
  - adalimumab and certolizumab pegol may be effective and should be considered in treating perianal fistula (ACG Strong recommendation, Low-quality evidence)
    阿達木單抗和培塞利珠單抗可能有效，應考慮用於治療肛周瘺（ACG：強烈推薦，低質量證據）
  - thiopurines such as azathioprine or 6-mercaptopurine may be effective and should be considered in treating fistulizing disease (ACG Strong recommendation, Low-quality evidence)
    硫嘌呤類藥物，如硫唑嘌呤或 6-巯基嘌呤可能有效，應考慮用於治療瘺管性疾病（ACG 強烈推薦，低質量證據）
  - consider tacrolimus for short-term treatment of perianal and cutaneous fistulas (ACG Strong recommendation, Moderate-quality evidence); however, significant toxicities preclude long-term use
    考慮將他克莫司用於肛周和皮膚瘺的短期治療（ACG 強烈推薦，中等質量證據）;然而，嚴重的毒性會妨礙長期使用
  - antibiotics (imidazoles) may be effective and should be considered for treating simple perianal fistulas (ACG Strong recommendation, Moderate-quality evidence)
    抗生素（咪唑類）可能有效，應考慮用於治療單純性肛周瘺（ACG 強烈推薦，中等質量證據）
- PubMed29610508The American journal of gastroenterologyAm J Gastroenterol201804011134481-517481Reference - ACG clinical guideline on the management of Crohn disease in adults (Am J Gastroenterol 2018 Apr;113(4):481)
  參考資料 - ACG 成人克羅恩病管理臨床指南（Am J Gastroenterol 2018 年 4 月;113（4）：481）
proposed algorithm for management of Crohn disease perianal fistula, based on limited evidence
基於有限證據的 Crohn 病肛周瘺的擬議管理演算法
- for simple fistula without inflammation
  用於無炎症的單純性瘺管
  - first-line 一線治療
    - antibiotics plus immunomodulators such as azathioprine or 6-mercaptopurine
      抗生素加用免疫調節劑，如硫唑嘌呤或 6-巯基嘌呤
    - consider anti-tumor necrosis alpha antibodies (anti-TNF) such as infliximab, adalimumab, or certulizumab pegol
      考慮使用抗腫瘤壞死 α 抗體（抗 TNF），例如英夫利昔單抗、阿達木單抗或培乙二醇
  - if medical management is successful, continue maintenance regimen of immunomodulators with or without anti-TNF agents (if started)
    如果藥物治療成功，請繼續使用免疫調節劑聯合或不聯合抗 TNF 藥物的維持方案（如果開始）
  - if medical management fails
    如果藥物治療失敗
    - first-line is fistulotomy, second-line options include fibrin glue, fistula plug, or endorectal advancement flap
      一線是瘺管切開術，二線治療選擇包括纖維蛋白膠、瘺管栓或直腸內前移皮瓣
    - if ≥ 1 intervention fails, treat as complex fistula
      如果 1 ≥干預失敗，則視為複雜瘺管
- for simple fistula with inflammation
  用於伴有炎症的單純性瘺管
  - first-line is antibiotics plus immunomodulators (such as azathioprine or 6-mercaptopurine) and anti-TNF agents
    一線治療是抗生素加免疫調節劑（如硫唑嘌呤或 6-巯基嘌呤）和抗 TNF 藥物
  - consider monitoring healing with periodic imaging
    考慮通過定期影像學檢查監測癒合情況
  - if medical management is successful, continue maintenance regimen of immunomodulators and anti-TNF agents
    如果藥物治療成功，請繼續使用免疫調節劑和抗 TNF 藥物維持治療方案
  - if medical management fails, treat as complex fistula
    如果藥物治療失敗，應作為複雜瘺管治療
- for complex fistula (includes simple fistulas refractory to above management strategies)
  對於複雜瘺管（包括上述管理策略難治性的簡單瘺管）
  - first-line is combination of both of following interventions
    一線治療是以下兩種干預措施的結合
    - non-cutting seton placement
      非切割掛線貼裝
    - antibiotics plus immunomodulators (such as azathioprine or 6-mercaptopurine) and anti-TNF agents
      抗生素加用免疫調節劑（如硫唑嘌呤或 6-巯基嘌呤）和抗 TNF 藥物
  - consider monitoring healing with periodic imaging
    考慮通過定期影像學檢查監測癒合情況
  - if first-line interventions effective, remove seton and continue maintenance regimen with immunomodulators (such as azathioprine or 6-mercaptopurine) and anti-TNF agents
    如果一線干預有效，則去除掛線並繼續使用免疫調節劑（如硫唑嘌呤或 6-巯基嘌呤）和抗 TNF 藥物維持治療方案
  - if first-line interventions fail, options include either of following
    如果一線干預失敗，選項包括以下任一
    - consider tacrolimus (reported to have efficacy for reducing short-term drainage but not for inducing complete cessation of drainage, and is associated with nephrotoxicity)
      考慮他克莫司（據報導對減少短期引流有效，但對誘導完全停止引流無效，並且與腎毒性相關）
    - consider proctectomy 考慮直腸切除術
- Reference - Inflamm Bowel Dis 2015 Apr;21(4):723
  參考資料 - Inflamm Bowel Dis 2015 年 4 月;21（4）：723

Surgical Recommendations 手術建議

British Society of Gastroenterologists (BSG) 2019 recommendations on surgery for Crohn disease
英國胃腸病醫師協會（BSG） 2019 年關於克羅恩病手術的建議
- fistulizing disease 瘺管性疾病
  - surgically resect enterovaginal and enterovesicle fistulas in combination with medical inflammation control (BSG Strong recommendation, very low-quality evidence)
    手術切除腸陰道瘺和腸囊瘺聯合軀體炎症控制（BSG 強烈推薦，極低質量證據）
  - surgery typically required for high-volume enterocutaneous fistulas (BSG Weak recommendation, very low-quality evidence)
    大容量腸皮瘺通常需要手術（BSG 弱推薦，極低質量證據）
  - only offer surgical options for perianal fistula after counseling as long-term results are poor particularly if complex disease or ongoing disease activity; options include
    僅在諮詢后提供肛周瘺的手術選擇，因為長期結果較差，特別是如果疾病複雜或疾病持續活動;選項包括
    - advancement flap 進度翻板
    - LIFT procedure LIFT 手術
    - infill procedures 填充程式
- for severe perianal disease refractory to medical therapy, consider fecal stream diversion and counsel patient on low rate of successful reversals and possibility of proctectomy ultimately being required (BSG Strong recommendation, low-quality evidence)
  對於藥物治療難治性的嚴重肛周疾病，考慮糞便流改道，並告知患者逆轉成功率低，最終需要直腸切除術的可能性（BSG 強烈推薦，低質量證據）
- PubMed31562236GutGut2019120168Suppl 3s1-s106s1Reference - BSG consensus guidelines on the management of inflammatory bowel disease in adults (Gut 2019 Dec;68(Suppl 3):s1)
  參考資料 - BSG 成人炎症性腸病管理共識指南（腸道 2019 年 12 月;68（增刊 3）：s1）
recommendations for management of fistula in ano associated with Crohn disease from American Society of Colon and Rectal Surgeons (ASCRS) 2016 guidelines¹
美國結腸直腸外科醫師協會（ASCRS） 2016 年指南中關於克羅恩病相關 ANO 瘺管管理的建議 ¹
- asymptomatic fistulas in patients with Crohn disease do not require surgical intervention (ASCRS Grade 1C)
  克羅恩病患者的無癥狀瘺管不需要手術干預（ASCRS 1C 級）
- fistulotomy for symptomatic, simple, low Crohn fistula may be used (ASCRS Grade 1C)
  對於有癥狀的、簡單的、低位的克羅恩瘺，可以使用瘺管切開術（ASCRS 1C 級）
  - maximum preservation of sphincter function essential - consider all relevant patient factors including extent of anorectal disease, sphincter status and continence, rectal compliance, presence of active proctitis, previous anorectal operations, and stool consistency
    最大限度地保留括約肌功能至關重要 - 考慮所有相關的患者因素，包括肛門直腸疾病的範圍、括約肌狀態和節制、直腸順應性、活動性直腸炎的存在、既往肛門直腸手術史和糞便稠度
  - wound healing in this patient population may be delayed by 3-6 months
    該患者群體的傷口癒合可能會延遲 3-6 個月
- loose setons for multimodal therapy for perianal Crohn disease and long-term disease control may be used (ASCRS Grade 1C)
  可使用鬆散的 seton 進行肛周克羅恩病的多模式治療和長期疾病控制（ASCRS 1C 級）
  - may allow continuous drainage and inflammation resolution
    可促進持續引流和炎症消退
  - reported 20%-40% of patients develop recurrent infection; and reported 8%-13% of patients develop fecal soilage
    報告 20%-40% 的患者發生復發性感染;並報告 8%-13% 的患者出現糞便污染
- endoanal advancement flap, anal fistula plug, and LIFT in Crohn fistula may be used (ASCRS Grade 2B); contraindicated if patient has active proctitis
  在克羅恩瘺中，可以使用肛門內推進皮瓣、肛瘺栓和 LIFT（ASCRS 2B 級）;如果患者患有活動性直腸炎，則禁忌
- permanent diversion or proctectomy for uncontrollable symptoms in Crohn fistula may be required (ASCRS Grade 1C)
  對於克羅恩瘺無法控制的癥狀，可能需要進行永久性改道或直腸切除術（ASCRS 1C 級）
  - may be needed in patients with extensive, aggressive disease uncontrolled by medical management
    對於藥物治療無法控制的廣泛性侵襲性疾病患者，可能需要進行此項檢查
  - indicated in long-term seton placement to control perianal infection
    適用於長期放置掛線以控制肛周感染

Tumor Necrosis Factor Inhibitors for Perianal Disease
肛周疾病的腫瘤壞死因數抑製劑

STUDY SUMMARY 研究總結
infliximab associated with healing of fistulas
英夫利昔單抗與瘺管癒合相關
RANDOMIZED TRIAL: N Engl J Med 1999 May 6;340(18):1398
隨機試驗： N Engl J Med 1999 年 5 月 6 日;340（18）：1398
based on small randomized trial with unclear randomization method

94 adults with Crohn disease and draining abdominal or perianal fistulas at least 3 months randomized to infliximab 10 mg/kg vs. 5 mg/kg vs. placebo IV at weeks 0, 2, and 6

primary end point was ≥ 50% reduction in number of draining fistulas at ≥ 2 consecutive visits up to 18 weeks

comparing infliximab 10 mg/kg vs. 5 mg/kg vs. placebo
primary end point reached in 56% vs. 68% vs. 26% (p < 0.03 compared to placebo for each group, NNT 4 for 10 mg/kg, NNT 3 for 5 mg/kg)

closure of all fistulas in 38% vs. 55% vs. 13% (p ≤ 0.04 compared to placebo for each group, NNT 4 for 10 mg/kg, NNT 3 for 5 mg/kg)

adverse effects in 84% vs. 65% vs. 65%

most common adverse effects with infliximab were headache, abscess, upper respiratory tract infection, and fatigue

Reference - N Engl J Med 1999 May 6;340(18):1398

2 systematic reviews did not find additional trials of infliximab for healing fistulas in Crohn disease (Am J Gastroenterol 2011 Apr;106(4):644, Health Technol Assess 2011 Feb;15(6):1PDF)

Evidence Synopsis 證據概要

There is limited evidence regarding the efficacy of adalimumab or certolizumab pegol for perianal fistulas in Crohn disease. The 2018 American College of Gastroenterology guideline recommends considering these agents for treating perianal fistulas in Crohn disease based on weak evidence, and further clarifies the recommendation relies on secondary or post hoc analyses and observational data. A 2017 systematic review found that adalimumab and certolizumab pegol were associated with maintenance but not induction of fistula closure in adults.
關於阿達木單抗或培塞利珠單抗治療克羅恩病肛周瘺的療效的證據有限。2018 年美國胃腸病學會（American College of Gastroenterology）指南基於較弱的證據建議考慮使用這些藥物來治療克羅恩病的肛周瘺，並進一步闡明該建議依賴於二級或事後分析和觀察數據。2017 年的一項系統評價發現，阿達木單抗和培塞利珠單抗與成人瘺管閉合維持相關，但與誘導瘺管閉合無關。

adalimumab and certolizumab pegol may be effective and should be considered in patients with perianal fistula and Crohn disease (ACG Strong recommendation, Low-quality evidence) (Am J Gastroenterol 2018 Apr;113(4):481)
阿達木單抗和培塞利珠單抗可能有效，應考慮用於肛周瘺和克羅恩病患者（ACG 強烈推薦，低質量證據）（Am J Gastroenterol 2018 年 4 月;113（4）：481）
STUDY SUMMARY 研究總結
adalimumab and certolizumab pegol may be effective in maintaining fistula closure (but not fistula improvement or likelihood of closure) in adults with fistulizing Crohn disease
阿達木單抗和培塞利珠單抗可能有效維持成人瘺管性克羅恩病患者的瘺管閉合（但不能有效維持瘺管改善或閉合的可能性）
RANDOMIZED TRIAL: J Res Pharm Pract 2017 Jul-Sep;6(3):135
隨機試驗： J Res Pharm Pract 2017 年 7 月至 9 月;6（3）：135
based on systematic review of randomized trials with unclear allocation concealment

systematic review of 9 randomized trials comparing tumor necrosis factor antagonists (infliximab, adalimumab, and certolizumab pegol) to placebo in 774 patients with fistulizing Crohn disease

allocation concealment not assessed in any trials

compared to placebo, adalimumab and certolizumab pegol were associated with increased rate of fistula closure maintenance (maintaining remission in patients whose fistula has closed) (risk ratio 2.36, 95% CI 1.58-3.55) in analysis of 2 trials with 368 patients

no significant differences between groups in
fistula improvement (closure of 50% of fistula for at least 2 consecutive visits) in analysis of 2 trials with 123 patients

fistula closure (closure of 100% of fistula for at least 2 consecutive visits) in analysis of 2 trials with 193 patients

Reference - J Res Pharm Pract 2017 Jul-Sep;6(3):135
STUDY SUMMARY 研究總結
adalimumab may not improve healing of fistulas in Crohn disease
阿達木單抗可能無法改善克羅恩病患者瘺管的癒合
SYSTEMATIC REVIEW: Am J Gastroenterol 2011 Apr;106(4):644
系統評價： Am J Gastroenterol 2011 年 4 月;106（4）：644
based on systematic review with limited evidence

systematic review of 27 randomized trials comparing biologic therapies to placebo in adults (> 90% of patients of trial over age 16 years) with active or quiescent Crohn disease or ulcerative colitis

3 trials evaluated adalimumab for healing of fistulizing disease, of which 1 small trial was high quality

no significant difference between adalimumab and placebo for healing of fistulizing disease in analysis of 3 trials with 194 patients, results limited by significant heterogeneity

insufficient data to assess adverse events

Reference - Am J Gastroenterol 2011 Apr;106(4):644
STUDY SUMMARY 研究總結
certolizumab pegol does not appear effective for treating fistulas in patients with Crohn disease
Certolizumab pegol 似乎對治療克羅恩病患者的瘺管無效
SYSTEMATIC REVIEW: Am J Gastroenterol 2011 Apr;106(4):644
系統評價： Am J Gastroenterol 2011 年 4 月;106（4）：644
based on systematic review of trials with high dropout rates

systematic review of 27 randomized trials comparing biologic therapies to placebo in adults (> 90% of patients of trial over age 16 years) with active or quiescent Crohn disease or ulcerative colitis

2 trials evaluated certolizumab pegol for healing of fistulas in patients with Crohn disease

both trials had high dropout rates

no significant differences between placebo and certolizumab pegol for healing of fistulizing disease in analysis of 2 trials with 165 patients

insufficient data to assess adverse events

Reference - Am J Gastroenterol 2011 Apr;106(4):644, commentary can be found in Am J Gastroenterol 2011 Nov;106(11):2043, Am J Gastroenterol 2011 Nov;106(11):2045
STUDY SUMMARY 研究總結
certolizumab pegol associated with increased rate of fistula closure at 26 weeks in patients with Crohn disease who responded to induction therapy at 6 weeks
在對誘導治療有反應的克羅恩病患者 26 周時，賽妥珠單抗與瘺管閉合率增加相關
RANDOMIZED TRIAL: Aliment Pharmacol Ther 2011 Jan;33(2):185
隨機試驗： Aliment Pharmacol Ther 2011 年 1 月;33（2）：185
based on subgroup analysis of PRECiSE 2 randomized trial

108 patients with draining fistulas at baseline were treated with certolizumab pegol 400 mg at weeks 0, 2, and 4

58 patients with clinical response (CDAI decrease ≥ 100 points) at 6 weeks were randomized to certolizumab pegol 400 mg maintenance vs. placebo every 4 weeks through week 24

comparing certolizumab pegol vs. placebo at 26 weeks
100% fistula closure in 36% vs. 17% (p = 0.038, NNT 5)

partial fistula closure (≥ 50% at 2 consecutive postbaseline visits ≥ 3 weeks apart) in 54% vs. 43% (not significant)

mean time to fistula closure 13.3 days vs. 13.4 days (not significant)

Reference - Aliment Pharmacol Ther 2011 Jan;33(2):185

Antibiotic Efficacy for Perianal Disease
抗生素對肛周疾病的療效

STUDY SUMMARY 研究總結
ciprofloxacin 500 mg twice daily may increase rate of clinical response or remission in patients with Crohn disease and perianal fistula
環丙沙星 500 毫克，每天兩次，可增加克羅恩病和肛周瘺患者的臨床反應率或緩解率
SYSTEMATIC REVIEW: J Dig Dis 2015 Feb;16(2):58
系統評價： J Dig Dis 2015 年 2 月;16（2）：58
based on systematic review of trials with methodologic limitations

systematic review of 15 randomized trials comparing antibiotics vs. placebo for ≥ 4 weeks for inducing clinical improvement or remission in 1,407 patients with Crohn disease

clinical improvement defined as Crohn disease activity index (CDAI) reduction ≥ 7 points

remission defined as CDAI < 150 points

all trials evaluating patients with perianal fistula had ≥ 1 methodologic limitation, including unclear or no allocation concealment, unclear randomization, and/or small sample size

compared to placebo in analysis of 3 trials with 112 patients with perianal fistula, ciprofloxacin 500 mg twice daily for ≥ 4 weeks associated with increased rate of clinical response or remission (risk ratio 1.64, 95% CI 1.16-2.32), NNT 2-15 with response or remission in 42% of placebo group

Reference - J Dig Dis 2015 Feb;16(2):58
STUDY SUMMARY 研究總結
antibiotics may reduce perianal fistula drainage in patients with Crohn disease
抗生素可減少克羅恩病患者的肛周瘺管引流
SYSTEMATIC REVIEW: Am J Gastroenterol 2011 Apr;106(4):661
系統評價： Am J Gastroenterol 2011 年 4 月;106（4）：661
based on systematic review with limited evidence

systematic review of randomized trials comparing antibiotics to placebo or no intervention in adults with inflammatory bowel disease

3 trials with 123 patients evaluated ciprofloxacin or metronidazole in adults with perianal Crohn disease fistula

no trial was statistically significant individually

antibiotics (ciprofloxacin or metronidazole) associated with reduced perianal fistula drainage in analysis of 4 comparisons with 131 adults
relative risk 0.8 (95% CI 0.66-0.98)

NNT 5 (95% CI 3-20)

Reference - Am J Gastroenterol 2011 Apr;106(4):661
STUDY SUMMARY 研究總結
metronidazole ointment may reduce some symptoms of perianal Crohn disease without reduction in disease activity
甲硝唑軟膏可以減輕肛周克羅恩病的一些癥狀，但不會降低疾病活動度
RANDOMIZED TRIAL: Br J Surg 2010 Sep;97(9):1340
隨機試驗： Br J Surg 2010 年 9 月;97（9）：1340
based on randomized trial with inadequate power

74 adults with perianal Crohn disease were randomized to metronidazole 10% ointment vs. placebo ointment 0.7 grams applied 3 times daily for 4 weeks

metronidazole ointment associated with reduce perianal discharge (p = 0.012) and reduced perianal pain (p = 0.059)

no significant difference in reduction in perianal Crohn disease activity index

Reference - Br J Surg 2010 Sep;97(9):1340

Combination Biologics Plus Antibiotics for Perianal Disease
聯合生物製劑加抗生素治療肛周疾病

STUDY SUMMARY 研究總結
addition of ciprofloxacin to adalimumab therapy may increase rates of perianal fistula closure and clinical remission compared to adalimumab monotherapy at 12 weeks
與阿達木單抗單藥治療相比，在阿達木單抗治療中加入環丙沙星可能會增加 12 周時肛周瘺管閉合率和臨床緩解率
RANDOMIZED TRIAL: Gut 2014 Feb;63(2):292
隨機試驗：腸道 2014 年 2 月;63（2）：292
based on randomized trial with inadequate statistical power

76 adults (mean age 35 years) with active perianal fistulizing Crohn disease receiving adalimumab were randomized to addition of ciprofloxacin 500 mg twice daily vs. placebo for 12 weeks

adalimumab doses were subcutaneous and occurred once every 2 weeks; induction therapy consisted of 160 mg, second dose of 80 mg, then 40 mg for remaining doses

power to evaluate effect limited by lower-than-expected enrollment

comparing addition of ciprofloxacin vs. placebo at 12 weeks
closure of ≥ 50% of draining fistulas in 71% vs. 47% (p = 0.047, NNT 5)

clinical remission in 65% vs. 33% (p = 0.009, NNT 4)

comparing ciprofloxacin vs. placebo at 24 week follow-up (12 weeks after ciprofloxacin discontinuation)
closure of ≥ 50% of draining fistulas in 62% vs. 47% (not significant)

clinical remission in 53% vs. 33% (not significant)

Reference - ADAFI trial (Gut 2014 Feb;63(2):292)

Tacrolimus for Perianal Disease
他克莫司治療肛周疾病

consider tacrolimus for short-term treatment of perianal and cutaneous fistulas (ACG Strong recommendation, Moderate-quality evidence); significant toxicities preclude long-term use (Am J Gastroenterol 2018 Apr;113(4):481)
考慮將他克莫司用於肛周和皮膚瘺的短期治療（ACG 強烈推薦，中等質量證據）;顯著的毒性排除了長期使用（Am J Gastroenterol 2018 年 4 月;113（4）：481）
STUDY SUMMARY 研究總結
tacrolimus associated with closure of draining fistulas in approximately 28% of patients with Crohn disease
他克莫司與約 28% 的克羅恩病患者引流瘺的閉合相關
SYSTEMATIC REVIEW: Aliment Pharmacol Ther 2011 Dec;34(11-12):1282
系統評價：食品藥理學技術 2011 年 12 月;34（11-12）：1282
based on systematic review of mostly observational studies

systematic review of 11 studies (9 case series and 2 small randomized trials) evaluating tacrolimus in 163 patients with luminal or perianal Crohn disease

in 49 patients with perianal disease who had oral or IV tacrolimus
28.6% had closure of all draining fistula

38.8% had partial response (generally defined as ≥ 50% closure of draining fistula from baseline)

Reference - Aliment Pharmacol Ther 2011 Dec;34(11-12):1282
STUDY SUMMARY 研究總結
oral tacrolimus may improve but not resolve perianal fistulas in Crohn disease
口服他克莫司可能會改善但不能解決克羅恩病的肛周瘺管
RANDOMIZED TRIAL: Gastroenterology 2003 Aug;125(2):380
隨機試驗：胃腸病學 2003 年 8 月;125（2）：380
based on small randomized trial

48 patients with Crohn disease and draining perianal or enterocutaneous fistulas (42 with perianal fistulas) were randomized to tacrolimus 0.2 mg/kg/day vs. placebo orally for 10 weeks

comparing tacrolimus vs. placebo
fistula improvement (≥ 50% closure) in 43% vs. 8% (p = 0.004, NNT 3)

fistula remission in 10% vs. 8% (not significant)

38% of patients in tacrolimus group had nephrotoxicity (increase in baseline creatinine level ≥ 1.5 mg/dL [> 132 mcmol/L]) requiring dose reduction

Reference - Gastroenterology 2003 Aug;125(2):380

Fibrin Glue Injection 纖維蛋白膠注射

STUDY SUMMARY 研究總結
fibrin glue may be effective in healing of perianal fistulas in patients with Crohn disease
纖維蛋白膠可能有效治癒克羅恩病患者的肛周瘺管
RANDOMIZED TRIAL: Gastroenterology 2010 Jun;138(7):2275
隨機試驗：胃腸病學 2010 年 6 月;138（7）：2275
based on randomized trial without blinding

77 patients with Crohn Disease Activity Index (CDAI) ≤ 250 and fistulas between anus (or low rectum) and perineum, vulva, or vagina, draining for > 2 months stratified by presence of simple or complex fistulas, then randomized to fibrin glue injections into fistula tract vs. observation after removal of setons

magnetic resonance imaging or endosonography used to assess fistula tracts and absence of abscesses

clinical remission defined as absence of draining, perianal pain, or abscesses at week 8

comparing fibrin glue vs. observation
clinical remission in 38% vs. 16% (p = 0.04, NNT 5)

no significant difference in adverse events

Reference - Gastroenterology 2010 Jun;138(7):2275

Combination Medical and Surgical Management for Perianal Disease
肛周疾病的內外科聯合治療

STUDY SUMMARY 研究總結
combined medical and surgical treatment reported to have 52% remission rate in adults with fistulizing perianal Crohn disease
據報導，藥物治療和手術聯合治療對患有瘺管性肛周克羅恩病的成人患者的緩解率為 52%
SYSTEMATIC REVIEW: Aliment Pharmacol Ther 2014 Oct;40(7):741
系統評價： Aliment Pharmacol Ther 2014 年 10 月;40（7）：741
based on systematic review without direct comparison between groups

systematic review of 24 observational studies or case series evaluating combination therapy (medical plus surgical treatment) and/or single therapy (medical or surgical treatment alone) in 1,139 adults with fistulizing perianal Crohn disease

medical treatment was anti-tumor necrosis factor alpha (anti-TNF-alpha) therapy with or without immunomodulators

8 studies compared combination therapy to single therapy in 797 adults, however heterogeneity or incomplete reporting of healing data precluded meta-analysis

follow-up ranged from 3 to 69 months

clinical healing (complete remission) defined as clinical remission and lack of discharge from external opening of fistula track at last follow-up

in patients receiving combination therapy
complete remission in 52%

no response in 23%

in patients receiving single therapy
complete remission in 43%

no response in 34%

Reference - Aliment Pharmacol Ther 2014 Oct;40(7):741

Spherical Carbon Adsorbent
球形碳吸附劑

STUDY SUMMARY 研究總結
spherical carbon adsorbent does not reduce number of draining perianal fistulas in adults with Crohn disease
球形碳吸附劑不會減少克羅恩病成人患者的引流肛周瘺管數量
RANDOMIZED TRIAL: Inflamm Bowel Dis 2014 May;20(5):872
隨機試驗：炎症性腸病 2014 年 5 月;20（5）：872
based on randomized trial

249 adults (mean age 38 years) with Crohn disease (Crohn Disease Activity Index < 400) and ≥ 1 draining perianal fistula (mean 1.6 fistulae) were randomized to spherical carbon adsorbent 2 g orally 3 times daily vs. placebo for 8 weeks

89% of patients completed 8-week follow-up and were included in final analysis

comparing carbon adsorbent vs. placebo, no significant difference in proportion of patients with ≥ 50% reduction in number of draining fistula (13.9% vs. 16.5%)

Reference - FHAST-1 trial (Inflamm Bowel Dis 2014 May;20(5):872)

Procedural Efficacy 程式效果

surgical management reported to heal selected anal fistulas due to Crohn disease
據報導，手術治療可治癒克羅恩病引起的特定肛瘺
- retrospective case series of 59 patients (mean age 35 years) with Crohn disease and fistula in ano who were treated with surgical management and followed for mean 1.6 years
  回顧性病例系列研究納入了 59 例克羅恩病和肛瘺患者（平均年齡 35 歲），這些患者接受了手術治療並平均隨訪 1.6 年
- fistula characteristics
  瘺管特徵
  - high transsphincteric fistulae in 24 patients (44%)
    24 例患者（44%）出現高位經括約肌瘺
  - mid or low transsphincteric fistulae in 30 patients (51%)
    30 例患者（51%）出現中度或下度經括約肌瘺
  - rectovaginal fistula in 3 women (5%)
    3名女性（5%）的直腸陰道瘺
- all patients given ciprofloxacin 400 mg orally twice daily and metronidazole 500 mg orally 3 times daily up to 7 days postoperatively
  所有患者術后 7 天，環丙沙星 400 mg 口服，每日 2 次，甲硝唑 500 mg，口服，每日 3 次
- procedures included 包括的程式
  - fistulotomy in 29 patients (low or mid-level fistulas only), 1 patients received fistulotomy and proximal diverting colostomy,
    29 例患者（僅低或中水準瘺管）進行瘺管切開術，1 例患者接受瘺管切開術和近端分流結腸造口術，
  - loose seton placement in 25 patients with high fistulas, 1 patient received loose seton placement and proximal diverting colostomy
    25 例高位瘺管患者採用鬆散掛線放置，1 例接受鬆散掛線放置和近端分流結腸造口術
  - for the 3 women with rectovaginal fistula, 1 patient received total proctolectomy, 1 patient received loose seton placement, and 1 patient received levator ani muscle interposition and diverting colostomy
    3 例直腸陰道瘺女性患者，1 例接受全直腸切除術，1 例接受鬆散掛線放置，1 例患者接受肛提肌插入和分流結腸造口術
- recurrence in 2 (3.6%)
  2 例復發（3.6%）
  - 1 patient who received fistulotomy had failure to achieve wound healing
    1 例接受瘺管切開術的患者傷口癒合失敗
  - 1 patient who received seton placement had recurrence at 6 months
    1 例接受 Seton 放置的患者在 6 個月時復發
- of 55 patients who did not receive diverting stoma, 9 patients (16.3%) reported minor incontinence (defined as flatus and < 1 teaspoon mucus leakage in 24 hour period) during follow-up (6 of these patients had received fistulotomy and 3 had received seton placement)
  在 55 名未接受分流造口的患者中，9 名患者（16.3%）報告在隨訪期間出現輕度尿失禁（定義為腸胃脹氣和 24 小時內 <1 茶匙粘液滲漏）（其中 6 名患者接受了瘺管切開術，3 名接受了掛線放置）
- Reference - Scand J Surg 2017 Sep;106(3):211
  參考資料 - Scand J Surg 2017 年 9 月;106（3）：211
STUDY SUMMARY 研究總結
anal fistula (xenograft) plug reported to be associated with 39%-70% success rate in patients with Crohn disease
據報導，肛瘺（異種移植物）栓塞與克羅恩病患者 39%-70% 的成功率相關

SYSTEMATIC REVIEW: Dis Colon Rectum 2012 Mar;55(3):351
系統評價： Dis 結腸直腸 2012 年 3 月;55（3）：351
based on systematic review without assessment of study quality

systematic review of 18 studies (2 randomized trials) and 2 abstracts evaluating Surgisis anal fistula plug (bioabsorbable porcine xenograft) in 530 patients with anal fistula (42 patients had Crohn disease)

8 studies included patients with Crohn disease

study size ranged from 4 to 60 patients, operative technique and perioperative care varied among studies, as did prevalence of complex vs. simple fistulae

8.7% had plug extrusion

proportion of patients with Crohn disease achieving fistula closure was 55% (95% CI 39%-70%)

no changes in continence reported

Reference - Dis Colon Rectum 2012 Mar;55(3):351

Mesenchymal Stem Cell Injection
間充質幹細胞注射液

STUDY SUMMARY 研究總結
intralesional mesenchymal stem cell injection may increase remission of treatment-refractory perianal fistulas at 1 year in patients with Crohn disease
病灶內間充質幹細胞注射可增加克羅恩病患者 1 年難治性肛周瘺的緩解率
RANDOMIZED TRIAL: Lancet 2016 Sep 24;388(10051):1281
隨機試驗：柳葉刀 2016 年 9 月 24 日;388（10051）：1281
based on randomized trial with possible selection bias and follow-up study

212 adults (mean age 38 years) with Crohn disease and treatment-refractory, draining complex perianal fistulas were randomized to intralesional injection of allogeneic, adipose-derived mesenchymal stem cells (120 million cells in 24 mL) vs. 24 mL saline placebo and followed for 24 weeks
all patients had fistula curettage (95% had seton placement) ≥ 2 weeks before trial start, seton was removed before injection was administered

antibiotics were allowed for up to 4 weeks after injection, patients were allowed to continue immunomodulators and tumor necrosis factor inhibitors at stable doses during trial

patients were excluded if they had > 2 internal and > 3 external openings, had other treatment-refractory fistulas (such as rectovaginal or abdominal), or if they had prior surgery other than drainage and seton placement

54% in mesenchymal stem cell group and 39% in placebo group had concurrent antibiotic treatment at baseline (no p value reported)

remission defined as absence of draining fistulas despite gentle finger compression (clinical remission) plus absence of collections > 2 cm of treated fistulas on magnetic resonance imaging

outcome assessors were blinded

19% did not complete 24-week follow-up (most due to adverse events, considerable clinical deterioration, major protocol deviation, or consent withdrawal), all patients included in analyses

comparing mesenchymal stem cell injection vs. placebo at 24 weeks
remission in 50% vs. 34% (p = 0.024, NNT 7)

treatment-emergent adverse events in 17% vs. 29% (no p value reported)

no significant differences between groups in Perianal Disease Activity Index or quality of life

Reference - ADMIRE-CD trial (Lancet 2016 Sep 24;388(10051):1281), editorial can be found in Lancet 2016 Sep 24;388(10051):1251, commentaries can be found in Nat Rev Gastroenterol Hepatol 2016 Oct;13(10):560, Nature 2016 Dec 21;540(7634):S106

62% completed 1-year follow-up, 97% included in analysis

comparing mesenchymal stem cell injection vs. placebo at 1 year
remission in 56% vs. 38.6% (p = 0.01, NNT 6)

clinical remission in 59.2% vs. 41.6% (p = 0.013, NNT 3)

PubMed29277560GastroenterologyGastroenterology2018040115451334-1342.e41334Reference - Gastroenterology 2018 Apr;154(5):1334
STUDY SUMMARY 研究總結
intralesional mesenchymal stem cell injection associated with sustained remission at 2 or 3 years in > 50% of patients with Crohn disease
病灶內間充質幹細胞注射與 2 或 3 年持續緩解相關> 50% 的克羅恩病患者
COHORT STUDY: Inflamm Bowel Dis 2022 Jan 31 early online
佇列研究：炎症性腸病 2022 年 1 月 31 日提前上線
based on retrospective cohort study

89 patients who completed ≥ 1-year follow-up in ADMIRE-CD trial were followed for additional 1-2 years (total follow-up of 2-3 years)
43 patients (mean age 42 years) received intralesional mesenchymal stem cell injection

46 patients (mean age 37 years) received placebo

patients in both groups continued with concomitant therapies and management of complex perianal fistulas throughout study

comparing mesenchymal stem cell injection vs. placebo (all not significant)
clinical remission in
67.4% vs. 52.2% at 1 year

53.5% vs. 43.5% at 2 years

53.5% vs. 45.7% at 3 years

sustained clinical remission among 53 patients who had clinical remission at 1 year in
65.5% vs. 70.8% at 2 years

55.2% vs. 54.2% at 3 years

new fistula or fistula relapse at 3 years in 25.6% vs. 21.7%

Reference - Inflamm Bowel Dis 2022 Jan 31 early online

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Images 圖像

All (1) 所有（1）

Fistula treatment in Crohn disease
克羅恩病的瘺管治療

Fistula in Ano and Anorectal AbscessAno 和肛門直腸膿腫中的瘺管

Management 管理

Management Overview 管理概述

Antibiotics for Anorectal Abscess肛門直腸膿腫的抗生素

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Surgery and Procedures 手術和程式

Anorectal Abscess 肛門直腸膿腫

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Simple Fistula in AnoAno 中的簡單瘺管

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Complex Fistula in Ano Ano 中的複雜瘺管

Recommendations for Complex Fistula複雜瘺管的建議

Advancement Flaps 進度襟翼

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Ligation of Intersphincteric Fistula Tract (LIFT)括約肌間瘺束結紮術 （LIFT）

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Biomaterials 生物材料

Fibrin Glue 纖維蛋白膠

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Fistula Plugs 瘺管栓

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Collagen Injection 膠原蛋白注射液

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Autologous Stem Cell Injection自體幹細胞注射

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Video-assisted Anal Fistula Treatment (VAAFT)電視輔助肛瘺治療 （VAAFT）

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Endoscopic Clips 內窺鏡夾

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Laser Ablation and Electrocautery鐳射消融和電烙術

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Seton Placement Seton 放置

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Fistula Excision With Direct Sphincter Reconstruction瘺管切除術直接括約肌重建術

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Colostomy 結腸造口術

Vacuum Therapy With Endofistular Polyurethane Sponge 使用瘢下聚氨酯海綿進行真空療法

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Comparative Efficacy 比較功效

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Crohn Disease-associated Fistula克羅恩病相關瘺管

Approach to Remission Induction誘導緩解的方法

Surgical Recommendations 手術建議

Tumor Necrosis Factor Inhibitors for Perianal Disease肛周疾病的腫瘤壞死因數抑製劑

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Fistula in Ano and Anorectal Abscess
Ano 和肛門直腸膿腫中的瘺管

Antibiotics for Anorectal Abscess
肛門直腸膿腫的抗生素

Simple Fistula in Ano
Ano 中的簡單瘺管

Recommendations for Complex Fistula
複雜瘺管的建議

Ligation of Intersphincteric Fistula Tract (LIFT)
括約肌間瘺束結紮術（LIFT）

Autologous Stem Cell Injection
自體幹細胞注射

Video-assisted Anal Fistula Treatment (VAAFT)
電視輔助肛瘺治療（VAAFT）

Laser Ablation and Electrocautery
鐳射消融和電烙術

Fistula Excision With Direct Sphincter Reconstruction
瘺管切除術直接括約肌重建術

Vacuum Therapy With Endofistular Polyurethane Sponge
使用瘢下聚氨酯海綿進行真空療法

Crohn Disease-associated Fistula
克羅恩病相關瘺管

Approach to Remission Induction
誘導緩解的方法

Tumor Necrosis Factor Inhibitors for Perianal Disease
肛周疾病的腫瘤壞死因數抑製劑

Antibiotic Efficacy for Perianal Disease
抗生素對肛周疾病的療效

Combination Biologics Plus Antibiotics for Perianal Disease
聯合生物製劑加抗生素治療肛周疾病

Tacrolimus for Perianal Disease
他克莫司治療肛周疾病

Combination Medical and Surgical Management for Perianal Disease
肛周疾病的內外科聯合治療

Spherical Carbon Adsorbent
球形碳吸附劑

Mesenchymal Stem Cell Injection
間充質幹細胞注射液

DynaMed Levels of Evidence
DynaMed 證據級別

Quickly find and determine the quality of the evidence.
快速查找並確定證據的品質。

1Level 1 (likely reliable) Evidence
11 級（可能可靠）證據

2Level 2 (mid-level) Evidence
阿拉伯數位 2 級（中級）證據

3Level 3 (lacking direct) Evidence
33 級（缺乏直接）證據