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Original Contributions, Anorectal
原始貢獻， 肛門直腸
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Drainage Seton Versus External Anal Sphincter–Sparing Seton After Rerouting of the Fistula Tract in the Treatment of Complex Anal Fistula: A Randomized Controlled Trial
瘺管改道后引流掛線與肛門外括約肌保留掛線治療複雜性肛瘺：一項隨機對照試驗

Omar, Waleed M.B.B.Ch., M.D.Alqasaby, Abdallah M.B.B.Ch.Abdelnaby, Mahmoud M.B.B.Ch., M.D.Youssef, Mohamed M.B.B.Ch., M.D.Shalaby, Mostafa M.B.B.Ch., M.D.Anwar Abdel-Razik, Mohamed M.D.Emile, Sameh Hany M.B.B.Ch., M.D.
Omar， Waleed M.B.B.Ch.， 醫學博士阿卜杜拉·阿卜杜拉·M.B.B.Ch·阿爾卡薩比。Abdelnaby， Mahmoud M.B.B.Ch.， 醫學博士 Youssef， Mohamed M.B.B.Ch.， 醫學博士 Shalaby， Mostafa M.B.B.Ch.， 醫學博士 Anwar Abdel-Razik，穆罕默德醫學博士 Emile， Sameh Hany M.B.B.Ch.， 醫學博士

Abstract   抽象

BACKGROUND:   背景：

Complex anal fistula is one of the challenging anorectal conditions. Several treatments have been proposed for complex anal fistula, yet none proved to be ideal.
複雜性肛瘺是具有挑戰性的肛門直腸疾病之一。已經提出了幾種針對複雜性肛瘺的治療方法，但沒有一種被證明是理想的。

OBJECTIVE:   目的：

This randomized trial aimed to assess the efficacy of external anal sphincter–sparing seton in comparison with the conventional drainage seton in the treatment of complex anal fistula.
這項隨機試驗旨在評估保留肛門外括約肌的掛線與傳統引流掛線相比治療複雜肛瘺的療效。

DESIGN:   設計：

This was a prospective, randomized, single-blind controlled study.
這是一項前瞻性、隨機、單盲對照研究。

SETTINGS:   設定：

The study was conducted at the Colorectal Surgery Unit of Mansoura University Hospitals.
該研究是在曼蘇拉大學醫院的結直腸外科進行的。

PATIENTS:   病人：

Adult patients of both sexes with complex anal fistula were recruited and evaluated with MRI before surgery.
招募患有複雜肛瘺的成年男女患者，並在手術前進行 MRI 評估。

INTERVENTIONS:   干預：

Patients were randomly divided into 2 groups; group 1 was treated with conventional drainage seton and group 2 was treated with external anal sphincter–sparing seton using a rerouting technique.
將患者隨機分為2組;第 1 組用常規引流掛線處理，第 2 組用保留肛門外括約肌的掛線處理，使用改道技術。

MAIN OUTCOME MEASURES:   主要結局指標：

The duration of healing, incidence of recurrence or persistence, postoperative pain, and complications including fecal incontinence were measured.
測量癒合持續時間、復發或持續發生率、術后疼痛和併發症（包括大便失禁）。

RESULTS:   結果：

Sixty patients (56 men) with a mean age of 43 years were included. Mean operation time in group 1 was significantly shorter than group 2 (29.8 ± 4.3 vs 43.8 ± 4.5 min; p < 0.0001). The mean pain score at 24 hours in group 1 was 8.1 ± 1.6 versus 5.3 ± 1.3 in group 2 ( p < 0.0001). Five patients (17%) in group 1 experienced complications versus 2 (7%) in group 2. All of the patients in group 1 required a second-stage fistulotomy versus 2 patients (7%) in group 2 ( p < 0.0001). Time to complete healing in group 1 was significantly ( p < 0.0001) longer than group 2 (103 ± 47 vs 46 ± 18 d). Four patients (13%) in group 1 and 1 patient (3%) in group 2 experienced persistence or recurrence of anal fistula ( p = 0.35).
納入 60 例患者 （56 例男性），平均年齡為 43 歲。第 1 組的平均手術時間顯著短於第 2 組 （29.8 ± 4.3 vs 43.8 ± 4.5 分鐘; p < 0.0001）。第 1 組 24 小時的平均疼痛評分為 8.1 ± 1.6，而第 2 組為 5.3 ± 1.3 （p < 0.0001）。第 1 組有 5 名患者 （17%） 出現併發症，而第 2 組有 2 名患者 （7%）出現併發症。第 1 組的所有患者都需要進行第二期瘺管切開術，而第 2 組有 2 名患者 （7%） （p < 0.0001）。第 1 組完成癒合的時間顯著長 （p < 0.0001） 長於第 2 組 （103 ± 47 vs 46 ± 18 d）。第 1 組 4 例患者 （13%） 和第 2 組 1 例患者 （3%） 出現肛瘺持續或復發 （p = 0.35）。

LIMITATIONS:   局限性：

This was a single-center study with relatively small numbers in each group.
這是一項單中心研究，每組中的人數相對較少。

CONCLUSIONS:   結論：

Patients treated with external anal sphincter–sparing seton after rerouting of the fistula tract achieved quicker healing and less postoperative pain than those with conventional drainage seton. Postoperative complication and recurrence rates were comparable in both groups. See Video Abstract at http://links.lww.com/DCR/A963 .
與傳統引流掛線患者相比，在改變瘺管改道后接受保留肛門外括約肌掛線治療的患者癒合更快，術后疼痛更少。兩組術后併發症和復發率相當。請參閱 http://links.lww.com/DCR/A963 的視頻摘要 。

TRIAL REGISTRATION:   試用註冊：

Anal fistula is one of the most common anorectal conditions.
肛瘺是最常見的肛門直腸疾病之一。 Although simple anal fistulas can be adequately treated with fistulotomy, complex fistulas usually involve a significant portion of the external anal sphincter (EAS)
雖然單純性肛瘺可以通過瘺管切開術充分治療，但複雜性瘺通常涉及肛門外括約肌 （EAS） 的很大一部分 and represent a challenging condition that requires a more sophisticated approach.
並代表了一種具有挑戰性的情況，需要更複雜的方法。
Optimal treatment of complex anal fistula (CAF) should attain low recurrence rates, quick recovery, and a minimal rate of complications.
複雜性肛瘺 （CAF） 的最佳治療應實現低復發率、快速恢復和最低併發症發生率。 Methods for the treatment of CAF involve sphincter-sparing techniques to avoid the incidence of fecal incontinence (FI) postoperatively. Various sphincter-saving procedures were described for CAF, including seton placement, anal advancement flap, ligation of intersphincteric fistula tract, fistula laser closure, video-assisted anal fistula treatment, and fistula plug.
CAF 的治療方法包括保留括約肌技術，以避免術后大便失禁 （FI） 的發生。描述了 CAF 的各種保留括約肌的手術，包括掛線放置、肛門前移皮瓣、括約肌間瘺管結紮、瘺管鐳射閉合、視頻輔助肛瘺治療和瘺管栓。
Hippocrates first described the use of seton in the treatment of anal fistula.
希波克拉底首先描述了 seton 在肛瘺治療中的應用。 Although the placement of drainage seton has been considered a nondefinitive first step that sets up other, more definitive operations for the treatment of anal fistula, recent evidence suggested that drainage seton can be a definitive treatment for CAF.
儘管放置引流掛線被認為是非確定性的第一步，為治療肛瘺建立了其他更明確的手術，但最近的證據表明，引流掛線可以是 CAF 的確定性治療方法。, According to our experience, the use of drainage seton as a definitive treatment for CAF has been associated with a recurrence rate of ≈10%, whereas other authors reported recurrence rates of 6% and 7% after placement of a drainage seton.
根據我們的經驗，使用引流掛線作為 CAF 的根治性治療與 ≈10% 的復發率相關，而其他作者報告放置引流掛線后的復發率分別為 6% 和 7%。,, The mechanism by which a drainage seton acts as a definitive treatment of anal fistula is still not clear; it may be because the seton gradually erodes its way through the fistula tract and anal sphincter muscles or because the internal opening may move distally in the anal canal outside of the high-pressure zone, allowing the tract to heal, as implied previously.
引流掛線作為肛瘺根治性治療的機制尚不清楚;這可能是因為掛線逐漸侵蝕了瘺管和肛門括約肌，或者因為內部開口可能在高壓區外的肛管中向遠端移動，使肛管癒合，如前所述。
Placement of seton is typically used when the fistula tract is involving >30% of the EAS.
當瘺管涉及 >30% 的 EAS 時，通常使用掛線放置。 Attempts to reroute the fistula tract were made to preserve the EAS fibers and to hasten healing of the wound. Mann and Clifton
嘗試改變瘺管的路線以保留 EAS 纖維並加速傷口癒合。曼恩和克利夫頓 first introduced a transposition technique for the management of high anal and anorectal fistulas by rerouting the extrasphincteric portion of the tract into an intersphincteric position with immediate repair of the EAS and reported successful outcomes in terms of quick healing and preserved anal continence.
首先引入了一種轉位技術來管理肛門高位和肛門直腸瘺，方法是將肛門的括約肌外部分重新路由到括約肌間位置，並立即修復 EAS，並報告了在快速癒合和保持肛門節制方面的成功結果。
The present study aimed to evaluate the outcome of drainage seton with or without rerouting of the fistula tract in the treatment of CAF regarding healing time, postoperative pain, recurrence, and FI. We hypothesized that rerouting of the fistula tract and the seton to involve the internal anal sphincter (IAS) only, preserving the EAS muscles, would serve to hasten healing and decrease the incidence of recurrence and continence disturbances postoperatively. Although Zbar et al
本研究旨在評估伴或不伴瘺管改道的引流掛線治療 CAF 在癒合時間、術后疼痛、復發和 FI 方面的結果。我們假設瘺管和掛線的改道僅涉及肛門內括約肌 （IAS），保留 EAS 肌肉，將有助於加速愈合併降低術后復發和節制障礙的發生率。儘管 Zbar 等人 conducted a similar randomized trial that investigated the effect of a rerouting technique, the authors used an IAS-sparing technique in contrast to our technique that spared the EAS. We thought that excluding the bulky EAS muscles from the loop of the seton would serve to accelerate healing and decrease the incidence of postoperative FI by preserving the fibers of the EAS.
進行了一項類似的隨機試驗，調查了重新路由技術的效果，作者使用了保留 IAS 的技術，而我們的技術保留了 EAS。我們認為，將笨重的 EAS 肌肉從掛線環中排除將有助於通過保留 EAS 的纖維來加速愈合併降低術后 FI 的發生率。

PATIENTS AND METHODS   患者和方法

Study Design and Setting   研究設計和設置

This was a randomized, single-blind, controlled study on patients with CAF who were surgically treated in the Colorectal Surgery Unit of Mansoura University Hospitals in the period of February 2017 to February 2018. The protocol of the study has been approved by the institutional review board of Mansoura Faculty of Medicine. The registration number of the trial is NCT03636997.
這是一項隨機、單盲、對照研究，物件為 2017 年 2 月至 2018 年 2 月期間在曼蘇拉大學醫院結直腸外科接受手術治療的 CAF 患者。該研究方案已獲得曼蘇拉醫學院機構審查委員會的批准。試用版的註冊號為 NCT03636997。

Eligibility Criteria   資格

Adult patients of both sexes aged <65 years with CAF were included. CAFs were defined as high trans-sphincteric anal fistulas involving >30% of the EAS fibers and suprasphincteric, extrasphincteric, and horseshoe fistulas.
包括 <65 歲的 CAF 成年患者。CAFs 被定義為高位經括約肌肛瘺，涉及 >30% 的 EAS 纖維和括約肌上、括約肌外和馬蹄瘺。 We excluded the following patients: patients with simple anal fistula; acute anorectal sepsis; secondary anal fistula caused by IBD, sexually transmitted diseases, malignancy, or irradiation; associated anorectal conditions, such as hemorrhoids, anal fissure, rectal prolapse, or malignancy; a history of previous surgical treatment of anal fistula; and patients with symptoms of FI.
我們排除了以下患者： 單純性肛瘺患者;急性肛門直腸敗血症;由 IBD、性傳播疾病、惡性腫瘤或輻射引起的繼發性肛瘺;相關的肛門直腸疾病，例如痔瘡、肛裂、直腸脫垂或惡性腫瘤;既往肛瘺手術治療史;和有 FI 癥狀的患者。

Preoperative Assessment   術前評估

Detailed history was taken from the patients with regard to complaint and its duration, associated medical conditions, previous surgical operations, previous treatments of the current condition, presence of anal pain, and constipation. The continence state was assessed with Wexner incontinence score.
從患者那裡獲取了詳細的病史，包括主訴及其持續時間、相關醫療狀況、既往外科手術、當前狀況的既往治療、肛門疼痛的存在和便秘。用 Wexner 失禁評分評估尿失禁狀態。
Patients were examined in the left lateral position. Direct inspection of the anal verge was done to detect the number and site of external opening of the fistula and to exclude the presence of associated anal conditions. Digital rectal examination was performed to exclude coexisting anorectal conditions and to assess the anal sphincter tone. Anoscope was then inserted to exclude associated anorectal lesions. As per the policy of our unit, MRI fistulography was performed for all of the patients to assess the type and complexity of the anal fistula and to detect secondary tracts and supralevator extensions.
患者在左側臥位進行檢查。直接檢查肛緣以檢測瘺管外部開口的數量和部位，並排除相關肛門疾病的存在。進行直腸指檢以排除共存的肛門直腸疾病並評估肛門括約肌張力。然後插入肛門鏡以排除相關的肛門直腸病變。根據我們單位的政策，對所有患者進行了 MRI 瘺管造影，以評估肛瘺的類型和複雜性，並檢測繼發性束和提肌上延伸。

Random Sequence Generation and Blinding
隨機序列生成和盲法

Patients included in the study were randomly assigned to 1 of 2 groups; group 1 underwent placement of drainage seton and group 2 underwent rerouting of the seton and fistula tract around the IAS only, sparing the EAS muscles.
納入研究的患者被隨機分配到 2 組中的 1 組;第 1 組接受了引流掛線的放置，第 2 組僅接受了圍繞 IAS 的掛線和瘺管的改道，保留了 EAS 肌肉。
Randomization was undertaken by online randomization software ( www.randomization.com ). Allocation concealment was undertaken by the sealed envelope method. This study was single blind, because patients gave consent to participate in the study; however, they were not aware of the group that they were assigned to. The operating surgeons were aware of the nature of the study and allocation of the groups.
隨機化由在線隨機化軟體 （www.randomization.com ） 進行。分配隱藏採用密封信封法進行。這項研究是單盲的，因為患者同意參加這項研究;但是，他們不知道他們被分配到哪個組。手術外科醫生瞭解研究的性質和組的分配。

Surgical Technique   手術技術

Informed written consent to participate in the study was obtained from the patients. The nature of each procedure, potential benefits, and complications were clearly explained to each patient.
從患者那裡獲得參與研究的知情書面同意書。向每位患者清楚地解釋了每種手術的性質、潛在益處和併發症。
Patients were instructed to follow a brief mechanical bowel preparation in the form of a single rectal enema on the night before the operation and restricting oral intake to clear fluids 12 hours before the procedure. Procedures were performed by 3 consultants of colorectal surgery with experience in anal fistula surgery. Patients were placed in the modified lithotomy position, and the procedures were conducted under spinal anesthesia with 1 g of cefotaxime being administered intravenously on induction.
指導患者在手術前一晚以單次直腸灌腸的形式進行簡短的機械腸道準備，並在手術前 12 小時限制經口攝入以清除液體。手術由 3 名具有肛瘺手術經驗的結直腸外科顧問進行。將患者置於改良的截石位置，手術在脊髓麻醉下進行，誘導時靜脈注射 1 g 頭孢噻肟。
After insertion of the operating proctoscope, povidone iodine was injected through the external opening of the anal fistula to identify the location of the internal opening. Afterward, a malleable metallic probe was inserted into the external opening and guided gently until its tip came out of the internal opening.
插入手術直腸鏡后，通過肛瘺的外開口注入聚維酮碘，以確定內開口的位置。之後，將可延展的金屬探針插入外部開口並輕輕引導，直到其尖端從內部開口中出來。
Using electrocautery, the fistula tract was excised, starting from the external opening until the EAS fibers were identified. Then, a number 1 silk suture (EgySilk suture, Taisier-Med Group, Cairo, Egypt) was tied to the end of the metallic probe, and the probe was withdrawn gently from the internal opening.
使用電烙術，從外部開口開始切除瘺管，直到識別出 EAS 纖維。然後，將 1 號絲縫合線（EgySilk 縫合線，Taisier-Med Group，開羅，埃及）綁在金屬探針的末端，將探針輕輕地從內開口中拔出。
In group 1 (conventional drainage seton group), the 2 ends of the silk suture were tied loosely around the remaining part of the fistula tract, EAS, and IAS. In group 2 (EAS-sparing seton), after passing the silk suture through the remaining part of the tract, dissection into the intersphincteric plane was carried out by an artery forceps ( Fig. 1A), then the silk suture was rerouted across the intersphincteric plane ( Figs. 1B and C) and tied around the IAS only, sparing the EAS muscles ( Figs. 1D and E). The point where the fistula tract was passing through the EAS was closed with a polyglactin 3/0 suture (Vicryl suture, Ethicon, Johnson & Johnson, Somerville, NJ) ( Fig. 1F).
在第 1 組（常規引流掛線組）中，絲縫線的 2 端鬆散地系在瘺管、EAS 和 IAS 的剩餘部分上。在第 2 組（保留 EAS 的掛線）中，在將絲縫穿過束的剩餘部分後，用動脈鑷子解剖到括約肌間平面（ 圖 1A），然後將絲縫線重新穿過括約肌平面（ 圖 1B 和 C）並僅系在 IAS 上，保留 EAS 肌肉（ 圖 1D） 和 E）。瘺管穿過 EAS 的點用多乳蛋白 3/0 縫合線（Vicryl suture， Ethicon， Johnson & Johnson， Somerville， NJ）閉合（ 圖 1F）。
FIGURE 1. A, Dissection into the intersphincteric plane. B and C, Rerouting of the silk seton through the intersphincteric plane. D, Seton and fistula tract rerouted around the internal anal sphincter only. E, Final view after tying of the silk seton loosely around the fistula tract and the internal anal sphincter. F, Closure of the point of passage of the fistula tract through the external anal sphincter. EAS = external anal sphincter.

FIGURE 1.   圖 1.

A, Dissection into the intersphincteric plane. B and C, Rerouting of the silk seton through the intersphincteric plane. D, Seton and fistula tract rerouted around the internal anal sphincter only. E, Final view after tying of the silk seton loosely around the fistula tract and the internal anal sphincter. F, Closure of the point of passage of the fistula tract through the external anal sphincter. EAS = external anal sphincter.
A，解剖到括約肌間平面。B 和 C，絲掛絲通過括約肌間平面的重新佈線。D，Seton 和瘺管僅圍繞肛門內括約肌重新佈線。E，將絲掛線鬆散地系在瘺管和肛門內括約肌周圍的最終視圖。F，瘺管通過肛門外括約肌的通道閉合。EAS = 肛門外括約肌。

Postoperative Assessment and Follow-up
術后評估和隨訪

Postoperative pain was assessed at 24 hours after surgery by visual analog scale (VAS) from 0 to 10, where 0 indicated no pain and 10 implied the worst possible pain. Patients were discharged the next day to surgery with instructions to do a Sitz bath every 8 hours and after each bowel movement. Laxatives were prescribed for 1 week after surgery to avoid passing hard motion, which may cause anal bleeding and pain.
術后 24 小時通過視覺類比量表 （VAS） 從 0 到 10 評估術后疼痛，其中 0 表示沒有疼痛，10 表示最嚴重的疼痛。患者第二天出院接受手術，並指示每 8 小時和每次排便後進行一次坐浴。手術后 1 周開具瀉藥，以避免通過可能導致肛門出血和疼痛的劇烈運動。
Follow-up was scheduled in the outpatient clinic at 1 and 2 weeks and then at 1, 3, and 6 months postoperatively. Patients were assessed during follow-up by a surgical resident and a consultant of colorectal surgery who were unaware of the nature of the study and the group allocations.
計劃在術后 1 周和 2 周以及術后 1 、 3 和 6 個月在門診進行隨訪。在隨訪期間，一名外科住院醫師和一名結直腸外科顧問對患者進行了評估，他們不知道研究的性質和組分配。
During each follow-up visit the degree of healing of the anal wound, recurrence of anal fistula, complications, and continence state were recorded. At 1 week, postoperative pain was assessed using VAS from 0 to 10. At 1 month postoperatively, the continence state was assessed with Wexner incontinence score, and the affection of lifestyle in terms of physical, social, and sexual activities was evaluated by a simple questionnaire.
在每次隨訪期間，記錄肛門傷口的癒合程度、肛瘺復發、併發症和失禁狀態。1 周時，使用 VAS 從 0 到 10 評估術后疼痛。術后 1 個月，用 Wexner 尿失禁評分評估尿失禁狀態，通過簡單的問卷評估生活方式對身體、社交和性活動的影響。 In both groups, the seton was left in place until it fell out spontaneously. If the seton did not fall out spontaneously by 3 months postoperatively, the patient was admitted and underwent lay open of the remaining part of the fistula (fistulotomy), along with removal of the seton.
在兩組中，掛線都留在原位，直到它自發脫落。如果掛線在術後 3 個月內沒有自發脫落，則患者入院並接受瘺管剩餘部分的剖開（瘺管切開術）並切除掛線。

Outcomes of the Study   研究結果

The primary outcome of the trial was the time needed to achieve complete healing of anal fistula after spontaneous fall of seton or fistulotomy and removal of seton. The incidence of treatment failure, including either persistence or recurrence of anal fistula, was also considered a primary outcome.
該試驗的主要結局是 seton 自發跌倒或瘺管切開術並去除 seton 後實現痔瘺完全癒合所需的時間。治療失敗的發生率，包括肛瘺的持續或復發，也被認為是主要結局。
Complete wound healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge, as detected by physical examination. Persistence was defined as failure of complete healing of the anal fistula for >6 months.
傷口完全癒合定義為傷口完全上皮化，經體格檢查發現無外瘺管開口或肛周分泌物的證據。 持續性定義為 >6 個月肛瘺未能完全癒合。 Recurrence was defined as the clinical occurrence of the fistula after recovery of the surgical wound after removal or fall of seton, occurring within 1 year after the procedure.
復發定義為在手術后 1 年內去除或掉落掛線後手術傷口恢復后瘺管的臨床發生。 Secondary outcomes included operation time, postoperative pain, postoperative complications including FI, and lifestyle affection.
次要結局包括手術時間、術后疼痛、包括 FI 在內的術后併發症和生活方式影響。

Sample Size Calculation   樣本量計算

We estimated the sample size required for the study based on analysis of the primary end point (time needed to complete healing of anal fistula) in each group. Based on a previous randomized trial
我們根據對每組主要終點 （肛瘺完成癒合所需的時間） 的分析估計了研究所需的樣本量。基於先前的隨機試驗 that compared conventional seton and rerouting IAS-preserving seton, we assumed that the average time to complete healing was 12 weeks after conventional seton and 9 weeks after rerouting EAS-preserving seton. Accordingly, a minimum sample size of 56 patients, equally divided into 2 groups, was required to achieve study power of 80% with α set at 5%. To compensate for loss to follow-up and dropouts, 60 patients were ultimately included in the study. The sample size was calculated using special sample size and study power online software ( http://clincalc.com/Stats/SampleSize.aspx ).
比較常規 seton 和重新路由 IAS 保留 seton，我們假設完成癒合的平均時間為常規 seton 後 12 周和重新路由 EAS 保留 seton 後 9 周。因此，需要至少 56 名患者樣本量，平均分為 2 組，才能達到 80%的研究功效，α設置為 5%。為了補償失訪和退出，最終將 60 名患者納入研究。樣本量是使用特殊樣本量和研究能力在線軟體 （http://clincalc.com/Stats/SampleSize.aspx 計算的。

Statistical Analysis   統計分析

Data were analyzed by SPSS (version 23, IBM Corp, Armonk, NY). Continuous data were expressed as mean ± SD or median and range. Categorical variables were expressed as number and percentage. Student t test was used to process continuous data, and Fisher exact test or χ 2 test was used for categorical variables. P values <0.05 were considered significant.
數據通過 SPSS （version 23， IBM Corp， Armonk， NY） 進行分析。連續數據表示為 SD ±平均值或中位數和範圍。分類變數表示為數位和百分比。學生 t 檢驗用於處理連續數據，Fisher 精確檢驗或 χ 2 檢驗用於分類變數。 P 值 <0.05 被認為顯著。

RESULTS   結果

Patient Characteristics   患者特徵

Among 102 patients with anal fistula who were initially evaluated, 60 patients with CAF were included in this prospective, randomized clinical study. The process of patient selection and exclusion is illustrated in the CONSORT flow chart ( Fig. 2).
在最初評估的 102 名肛瘺患者中，60 名 CAF 患者被納入這項前瞻性隨機臨床研究。患者選擇和排除的過程在 CONSORT 流程圖中說明（ 圖 2）。
FIGURE 2. CONSORT flow chart illustrating the process of patient selection and exclusion.

FIGURE 2.   圖 2.

CONSORT flow chart illustrating the process of patient selection and exclusion.
說明患者選擇和排除過程的 CONSORT 流程圖。
Patients included 56 men (93%) and 4 women (7%), with a mean age of 43 ± 11 years (range, 19–60 y). Patients were randomly assigned to 1 of 2 equal groups; group 1 was treated with conventional drainage seton, and group 2 was treated with EAS-sparing seton using a rerouting technique.
患者包括 56 名男性 （93%） 和 4 名女性 （7%），平均年齡為 43±11 歲（範圍，19-60 歲）。患者被隨機分配到 2 個相等的組中的 1 個;第 1 組用常規引流線處理，第 2 組用保留 EAS 的線線使用改道技術處理。
All of the patients (100%) complained of perianal discharge, 46 (77%) complained of anal pain, and 12 (20%) complained of pruritus ani. The mean duration of complaint was 11 ± 7 months (range, 1–24 mo). Five patients (17%) had diabetes mellitus and 3 had hypertension.
所有患者 （100%） 都抱怨肛周分泌物，46 名 （77%） 抱怨肛門疼痛，12 名 （20%） 抱怨肛門瘙癢。平均抱怨持續時間為11±7個月（範圍，1-24個月）。5 例患者 （17%） 患有糖尿病，3 例患有高血壓。

Characteristics of Anal Fistula
肛瘺的特徵

According to MRI, 56 patients (93%) patients had high trans-sphincteric anal fistula, 2 (3%) had horseshoe fistula, and 2 (3%) had suprasphincteric fistula. The external opening was located anteriorly in 21 patients (35%), posteriorly in 29 patients (48%), laterally in 9 (15%), and in 1 patients there was >1 external opening. All of the patients had a singular internal opening at the level of the dentate line. The 2 groups had no significant differences in regard to patient age, sex, clinical presentation, and type of anal fistula, as shown in Table 1.
MRI 顯示 56 例 （93%） 患者有高位跨括約動脈肛瘺，2 例 （3%） 有馬蹄瘺，2 例 （3%） 有括約肌上瘺。21 例患者 （35%） 外部開口位於前部，29 例患者 （48%） 位於後部，9 例患者 （15%） 位於外側開口，1 例患者存在 >1 外部開口。所有患者在齒狀線水準都有一個單一的內部開口。如 表 1 所示 ，兩組在患者年齡、性別、臨床表現和肛瘺類型方面無顯著差異。
TABLE 1. Characteristics of patients in both groups

TABLE 1.   表 1.

Characteristics of patients in both groups
兩組患者特徵

Operation Time   作時間

The mean operation time in group 1 was significantly shorter than in group 2 (29.8 ± 4.3 vs 43.8 ± 4.5 min; p < 0.0001).
第 1 組的平均手術時間顯著短於第 2 組 （29.8 ± 4.3 vs 43.8 ± 4.5 min; p < 0.0001）。

Postoperative Pain   術后疼痛

The mean pain VAS at 24 hours in group 1 was 8.1 ± 1.6 versus 5.3 ± 1.3 in group 2 ( p < 0.0001). Similarly, the mean pain VAS at 1 week after surgery in group 1 was significantly higher than in group 2 (5.5 ± 1.6 vs 3.3 ± 1.3; p < 0.0001).
第 1 組 24 小時的平均疼痛 VAS 分別為 8.1 ± 1.6，而第 2 組分別為 5.3 ± 1.3 （p < 0.0001）。同樣，第 1 組術后 1 周的平均疼痛 VAS 顯著高於第 2 組 （5.5 ± 1.6 vs 3.3 ± 1.3; p < 0.0001）。

Complications   併發症

Five patients (17%) in group 1 experienced complications: 2 developed anal bleeding and 3 complained of minor FI. Two patients (7%) in group 2 experienced minor FI ( Table 2).
第 1 組中 5 例患者 （17%） 出現併發症： 2 例發生肛門出血，3 例主訴輕度 FI。第 2 組中的 2 例患者 （7%） 出現輕度 FI（ 表 2）。
TABLE 2. Outcome of drainage seton and EAS-sparing seton

TABLE 2.   表 2.

Outcome of drainage seton and EAS-sparing seton
引流掛線和保留 EAS 的掛線的結局
FI recorded in both groups was of minor grade, with no significant difference in Wexner incontinence score noted between the 2 groups (mean Wexner score = 0.56 ± 1.3 in group 1 vs 0.4 ± 1.06 in group 2; p = 0.6). Continence disturbance was temporary and showed spontaneous improvement within 3 months in all of the patients.
兩組記錄的 FI 均為輕微級別，兩組之間的 Wexner 尿失禁評分無顯著差異（平均 Wexner 評分 = 0.56 ±第 1 組為 1.3，第 2 組為 0.4 ± 1.06; p = 0.6）。失禁障礙是暫時的，所有患者在 3 個月內均表現出自發改善。

Healing and Recurrence   癒合和復發

All of the patients (100%) in group 1 required a second-stage fistulotomy to remove the seton and remaining part of the fistula tract versus 2 patients (7%) in group 2 who required a second-stage fistulotomy ( p < 0.0001).
第 1 組的所有患者 （100%） 都需要第二產期瘺管切開術以去除掛線和瘺管的剩餘部分，而第 2 組 2 名患者 （7%） 需要第二產期瘺管切開術 （p < 0.0001）。
The time to complete healing in group 1 was 103 ± 47 days (range, 35–240 d), significantly ( p < 0.0001) longer than in group 2 (46 ± 18 d; range, 19–90 d). Healing was completed by 12 weeks in 9 patients in group 1 and 29 in group 2 and completed by 24 weeks in 19 patients in group 1 and 1 patient in group 2 ( p < 0.0001). Two patients (7%) in group 1 required >24 weeks (6 months) to achieve complete healing and were considered to have persistent anal fistula.
第 1 組完成癒合的時間為 103 ± 47 天 （範圍，35-240 d），顯著 （p < 0.0001） 比第 2 組 （46 ± 18 d;範圍，19-90 d）長。第 1 組 9 例患者和第 2 組 29 例患者在 12 周內完成癒合，第 1 組 19 例患者和第 2 組 1 例患者在 24 周內完成癒合 （p < 0.0001）。第 1 組中的 2 例患者 （7%） 需要 >24 周 （6 個月） 才能完全癒合，並被認為患有持續性肛瘺。
After a mean follow-up period of 12 ± 3 months (range, 10–19 mo), 4 patients (13%) in group 1 and 1 patient (3%) in group 2 experienced persistence or recurrence of anal fistula ( p = 0.35). Recurrence of anal fistula was in the form of trans-sphincteric fistula in 3 patients (all in group 1) and intersphincteric fistula in 2 patients (1 in each group; Table 2).
平均隨訪 12 ± 3 個月 （範圍，10-19 個月） 後，第 1 組 4 名患者 （13%） 和第 2 組 1 名患者 （3%） 經歷了肛瘺的持續性或復發 （p = 0.35）。肛瘺復發表現為經括約肌瘺 3 例 （均在第 1 組） 和 2 例患者括約肌間瘺 （每組 1 例; 表 2）。

Affection of Lifestyle After Surgery in Both Groups
兩組手術后生活方式的影響

As demonstrated in Table 3, the affection of lifestyle was comparable in both groups at 1 month after surgery, with no significant differences recorded in terms of physical, social, and sexual activities ( p = 0.7, 0.59, and 0.67).
如表 3 所示 ，手術后 1 個月兩組的生活方式影響相當，在身體、社交和性活動方面沒有顯著差異 （p = 0.7、0.59 和 0.67）。
TABLE 3. Affection of lifestyle after drainage seton and EAS-sparing seton

TABLE 3.   表 3.

Affection of lifestyle after drainage seton and EAS-sparing seton
引流掛線和保留 EAS 掛線后生活方式的影響

DISCUSSION   討論

Drainage seton has been used by many surgeons as a first stage in the treatment of CAF.
引流掛線已被許多外科醫生用作治療 CAF 的第一階段。 However, it can also be used as a definitive treatment for most complex fistulas, as demonstrated in previous studies,
然而，它也可以用作大多數複雜瘺管的確定性治療方法，如以前的研究所證明的那樣，, with success rates <90%.
成功率 <90%。
In this prospective randomized trial we included 60 patients with CAF with confirmed diagnosis by MRI. The vast majority of patients were men of middle age, in agreement with the male predominance of anal fistula in our community, as documented previously.
在這項前瞻性隨機試驗中，我們納入了 60 例通過 MRI 確診的 CAF 患者。絕大多數患者是中年男性，這與我們社區中男性肛瘺佔主導地位一致，如前所述。 We excluded patients aged >65 years, because they tend to have medical comorbidities that may affect healing of the anal wound after surgery. In addition, the effect of aging on the anal sphincters and anorectal function may result in a higher incidence of FI in patients >65 years of age, which might confound the results of the trial. We also thought the compliance of elderly patients with the follow-up schedule of our study could have been difficult and would result in a higher rate of loss to follow-up.
我們排除了 >65 歲的患者，因為他們往往患有可能影響術后肛門傷口癒合的醫學合併症。此外，衰老對肛門括約肌和肛門直腸功能的影響可能導致 >65 歲患者 FI 的發生率更高，這可能會混淆試驗結果。我們還認為老年患者對我們研究的隨訪計劃的依從性可能很困難，並且會導致更高的失訪率。
Patients were randomly assigned to 1 of 2 equal groups; the first group was treated with conventional drainage seton involving both IAS and EAS, whereas the second group was treated with EAS-sparing seton. Previous studies
患者被隨機分配到 2 個相等的組中的 1 個;第一組用涉及 IAS 和 EAS 的常規引流線處理，而第二組用保留 EAS 的線線處理。以前的研究,, assessed the outcome of rerouting of the fistula tract in high and CAF; however, the present study is the first randomized trial to compare the outcome of conventional drainage seton and EAS-sparing seton after rerouting of the fistula tract.
評估了 High 和 CAF 中瘺管改道的結果;然而，本研究是第一個比較瘺管改道后常規引流掛線和保留 EAS 的掛線結果的隨機試驗。
The EAS-sparing seton technique had significantly shorter time to achieve complete healing compared to the conventional drainage seton technique, which required >3 months to achieve complete healing of anal fistula. The mean time to complete healing after EAS-sparing seton was ≈6 weeks, in line with Lim et al,
與傳統的引流掛線技術相比，保留 EAS 的掛線技術實現完全癒合的時間明顯更短，傳統的引流掛線技術需要 >3 個月才能實現肛瘺的完全癒合。保留 EAS 的掛線后完全癒合的平均時間為 ≈6 周，與 Lim 等人一致， yet shorter than the median healing time (9 wk) reported by Buchanan et al.
但比 Buchanan 等人報告的中位癒合時間 （9 wk） 短。 However, because 30% of patients in the series published by Buchanan et al
然而，由於 Buchanan 等人發表的系列中 30% 的患者 had anal fistulas secondary to Crohn’s disease, the longer duration to complete healing in their study may be understandable.
患有繼發於克羅恩病的肛瘺，在他們的研究中完成癒合的時間較長可能是可以理解的。
In our trial, >95% of patients who were treated with EAS-sparing seton achieved complete healing by 3 months, whereas most patients who underwent conventional drainage seton required 6 months to achieve complete healing of fistula. Quicker healing after rerouting of the fistula tract may be explained because the silk seton was transposed to encompass the IAS only, preserving the EAS fibers, thus the amount of sphincter fibers included within the loop of seton was much less, and the rate of division of the tract and spontaneous falling of seton was accelerated to be completed within a few weeks. Only 2 patients in the rerouting group required a second-stage fistulotomy, whereas all of the patients who were treated with conventional drainage seton required a second stage for division of the remaining tract and removal of the seton followed by gradual healing of the fistula, which prolonged the total time needed for complete healing since the first procedure.
在我們的試驗中，>95% 接受保留 EAS 的掛線治療的患者在 3 個月時完全癒合，而大多數接受常規引流掛線的患者需要 6 個月才能實現瘺管完全癒合。瘺管改道後癒合更快可能是因為絲掛線被轉座以僅包含 IAS，保留了 EAS 纖維，因此掛線環中包含的括約肌纖維的數量要少得多，並且束的分裂和掛線的自發下降速度加快，在幾周內完成。改道組中只有 2 名患者需要第二階段瘺管切開術，而所有接受常規引流掛線治療的患者都需要第二階段進行剩餘束的分裂和掛線的切除，然後瘺管逐漸癒合，這延長了自第一次手術以來完全癒合所需的總時間。
Postoperative pain after rerouting of the fistula tract was not investigated in the previous trials. We found postoperative pain after EAS-sparing seton significantly less than the conventional seton, which may be logical, because less tissues were involved within the loop of seton compared with the conventional drainage seton, which included a thicker bulk of anal sphincter fibers. It has been reported that traction on the EAS fibers by seton may cause discomfort to the patients.
在以前的試驗中，沒有調查瘺管改道后的術后疼痛。我們發現保留 EAS 的掛線后術后疼痛明顯小於常規掛線，這可能是合乎邏輯的，因為與傳統引流掛線相比，掛線環內涉及的組織更少，其中包括較厚的肛門括約肌纖維。據報導，掛線對 EAS 纖維的牽引可能會引起患者的不適。
There were no significant differences between the 2 groups regarding the incidence of FI and postoperative incontinence score. This finding was in line with a previous randomized trial
2 組在 FI 發生率和術后失禁評分方面無顯著差異。這一發現與之前的一項隨機試驗一致 that found similar rates of FI between conventional seton and IAS-preserving seton. The rate of FI after EAS-sparing seton in our series was 7%, close to the incidence reported after IAS-sparing seton (6%), yet larger than the incidence of FI (3.8%) after staged drainage seton reported by Lim et al.
發現常規 seton 和 IAS 保留 seton 之間的 FI 率相似。在我們的系列中，EAS 保留掛線后的 FI 發生率為 7%，接近 IAS 保留掛線後報告的發生率 （6%），但高於 Lim 等人報告的分期引流掛線後 FI 的發生率 （3.8%）。 Incontinence in our trial and the previous studies
我們的試驗和以前的研究中的尿失禁, was of minor grade, mostly to flatus, and was a transient event showing spontaneous improvement within a few months. Similarly, both groups were comparable in regard to postoperative complication rates.
是輕微級別，主要是腸胃脹氣，並且是短暫事件，在幾個月內顯示自發改善。同樣，兩組在術后併發症發生率方面具有可比性。
On follow-up, 2 patients in the conventional drainage seton group had persistent anal fistula that warranted readjustment of seton in the operation theater, whereas none of the EAS-sparing seton group presented with persistent anal fistula. After removal or spontaneous fall of seton, another 2 patients in the conventional drainage seton group experienced recurrence within 6 months after complete healing of fistula compared with 1 patient in the rerouting group. The difference in recurrence rate between the 2 groups was insignificant, in concordance with previous investigators.
在隨訪中，常規引流掛線組中的 2 例患者存在持續性肛瘺，需要在手術室重新調整掛線，而保留 EAS 的掛線組均未出現持續性肛瘺。掛線移除或自發掉落後，常規引流掛線組另有 2 例患者在瘺管完全癒合后 6 個月內復發，而改道組有 1 例患者。兩組之間復發率的差異不顯著，與以前的研究者一致。, The only drawback of rerouting of the fistula tract with preservation of the EAS was longer operation time than conventional seton, which is reasonable because of the time consumed in meticulous dissection, repositioning of the fistula tract, and repair of the EAS muscles.
在保留 EAS 的情況下改變瘺管路線的唯一缺點是手術時間比傳統掛線長，這是合理的，因為細緻的解剖、瘺管重新定位和 EAS 肌肉修復會花費時間。
Although preoperative antibiotic prophylaxis for anorectal surgery has no established benefit and is not recommended by the American Society of Colon and Rectal Surgeons guidelines,
儘管肛門直腸手術的術前預防性抗生素沒有確定的益處，並且美國結腸直腸外科醫師協會 （American Society of Colon and Rectal Surgeons） 指南不推薦使用抗生素， we used antibiotic prophylaxis in the present trial because we considered it important, especially in patients with diabetes mellitus, based on our personal experience. Broad-spectrum antibiotics may still be administered intravenously before the start of anal fistula surgery, as implied in a recent UpToDate report.
我們在本試驗中使用了抗生素預防，因為根據我們的個人經驗，我們認為它很重要，尤其是對糖尿病患者。廣譜抗生素仍可在肛瘺手術開始前靜脈給葯，最近的 UpToDate 報告暗示了這一點。
Limitations of the present study include being a single center trial that included a relatively small numbers of patients; hence, multicenter studies composed of larger numbers of patients with longer follow-up are needed to ascertain the positive preliminary results of the trial. The trial was single blinded, because the operating surgeons and the outcome assessors were aware of the procedures performed. The vast majority of patients were men; the shorter anal canal and weaker anal sphincters in women may predispose to a higher rate of FI. Data on the BMI of patients were not complete, thus we could not investigate the impact of obesity on the outcome of surgery in both groups.
本研究的局限性包括是一項納入相對較少患者的單中心試驗;因此，需要由大量患者組成的多中心研究，隨訪時間更長，以確定試驗的積極初步結果。該試驗是單盲的，因為手術外科醫生和結局評估者都知道所進行的手術。絕大多數患者是男性;女性肛管較短和肛門括約肌較弱可能易患 FI 的發生率較高。患者 BMI 數據不完整，因此我們無法調查肥胖對兩組手術結果的影響。

CONCLUSION   結論

EAS-sparing seton conferred quicker healing and less postoperative pain than conventional seton. Postoperative complication and recurrence rates and affection of lifestyle were comparable in both groups.
與傳統掛線相比，保留 EAS 的掛線癒合更快，術后疼痛更少。兩組術后併發症和復發率以及生活方式的影響相當。

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