Clinical science  臨床科學

Ligation of intersphincteric fistula tract compared with advancement flap for complex anorectal fistulas requiring initial seton drainage
括約肌間瘺束結紮與前移皮瓣治療需要初始掛線引流的複雜肛門直腸瘺的比較

LIFT was a shorter procedure (median, 10.0 min; IQR, 7.5–11.0 min; vs ARAF, 42.5 min; IQR, 28.8–46.3 min; P < .001). On average, bowels opened on the second day after the procedure. There were no hospital readmissions. Pain was marginally higher in the ARAF group (1.0 vs .0; P = .017), although satisfaction scores were higher in the LIFT group (9.5) relative to the ARAF group (8.1; P < .001). Complications were 1 (4%) secondary bleed in the LIFT group and none in the ARAF group. Superficial wound dehiscence at the tip of the flap occurred in 1 (7%) ARAF participant and superficial perianal wound dehiscence occurred in 2 (8%) LIFT participants (Table 2). Overall, 12 (85%) ARAF and 17 (68%) LIFT patients healed in 1 month (P = .224). The time taken to resume normal activities was 1 week shorter after the LIFT procedure (1.0 vs 2.0; P = .016; Table 2).
LIFT 是一個較短的手術（中位數，10.0 分鐘;IQR，7.5-11.0 分鐘;vs ARAF，42.5 分鐘;IQR，28.8–46.3 分鐘;P < .001）.平均而言，手術后第二天腸道會打開。沒有再入院。ARAF 組的疼痛略高 （1.0 vs .0;P = .017），儘管 LIFT 組的滿意度得分 （9.5） 高於 ARAF 組 （8.1;P < .001）.併發症為 LIFT 組 1 例 （4%） 繼發性出血，ARAF 組無併發症。1 名 （7%） ARAF 參與者發生皮瓣尖端淺表傷口裂開，2 名 （8%） LIFT 參與者發生肛周淺表傷口裂開（ 表 2）。總體而言，12 名 （85%） ARAF 和 17 名 （68%） LIFT 患者在 1 個月內痊癒 （P = .224）。LIFT 手術后恢復正常活動所需的時間縮短了 1 周（1.0 vs 2.0;P = .016; 表 2）。

The major findings from this study were that the LIFT technique for the management of anal fistulas can be performed more rapidly and results in a better quality of life for the patient with less pain, a better satisfaction score, and faster resumption of normal activities than the ARAF technique. Although the overall recurrence rate was low (7.7%), there was no difference in recurrence rate between the 2 procedures.
這項研究的主要發現是，與 ARAF 技術相比，用於治療肛瘺的 LIFT 技術可以更快地進行，併為患者帶來更好的生活品質，疼痛更少，滿意度評分更高，恢復正常活動更快。雖然總體復發率較低 （7.7%），但 2 種手術的復發率沒有差異。

The LIFT technique divides the fistula tract in the intersphincteric space and prevents the entry of fecal material, eliminates sepsis related to the latter, and allows healing to occur. Our success rate of 92% for fistula healing compares well with the earliest published report of the LIFT procedure, particularly for complex fistulas.¹ Success rates for fistula healing have since been reported at 82.2% to 94.4%, however, the complexities of the fistulas were not specified.1, 12, 13 Bleier et al¹² reported a fistula closing rate of 57% in a study that included only complex fistula-in-ano. None of these studies have included patients with Crohn's disease. If this study were to be repeated now, based on all published reports, the sample size would be significantly larger.
LIFT 技術在括約肌間隙中分離瘺管並防止糞便進入，消除與後者相關的敗血症，並允許癒合。我們與最早發表的 LIFT 手術報告相比，我們的瘺管癒合成功率為 92%，尤其是對於複雜瘺管。¹ 此後，據報導瘺管癒合的成功率為 82.2% 至 94.4%，但未具體說明瘺管的複雜性。1， 12， 13 Bleier 等人 ¹² 在一項僅包括複雜肛瘺的研究中報告了 57% 的瘺管閉合率。這些研究均未納入克羅恩病患者。如果現在重複這項研究，根據所有已發表的報告，樣本量將明顯更大。

The challenge in the management of complex anorectal fistulas is to eradicate sepsis and also preserve fecal continence. Our low recurrence rates of 8% for the LIFT and 7% for the ARAF procedure compares well with various published techniques. Recent reports for mucosal advancement flaps have documented recurrence rates between 13% and 38%.14, 15, 16, 17, 18 Fibrin glue injections reportedly have been associated with a 40% to 84% recurrence rate, often depending on the length of follow-up time.19, 20, 21 The recurrence rate for the anal fistula plug has been reported as 57% to 76% in some series.22, 23 When inserted loosely, setons enable tract marking, stimulate fibrosis, and allow short- and long-term drainage of peri-anal sepsis from fistulas. They may be tied tightly to allow slow, controlled division of the enclosed sphincter mechanism with minimal separation of the transected ends.24, 25, 26 However, the latter also is known to result in significant incontinence. We believe that our low recurrence rates may be related to preliminary adequate drainage of the sepsis, allowing the definitive procedure to be performed in a relatively more favorable tissue healing environment after seton maturation over a 6-month period. In many circumstances, incorrect identification of the tract, even by millimeters, may contribute to recurrences. Hence, we consider our policy of revising the seton for persistent or recurrent fistulas and waiting at least 6 months after revision could help ensure the seton has enclosed the correct tract so that definitive surgery can be directed accurately. Although long-term setons may migrate through a portion of the sphincter and possibly cause an improved configuration of the fistula by converting the fistula tract from complex to simple, this did not seem to be the case in our study as evidenced by our EAUS at 6 months.
複雜肛門直腸瘺管理的挑戰是根除膿毒症並保持大便失禁。我們與各種已發表的技術相比，LIFT 的復發率低 8%，ARAF 手術的復發率低 7%。最近關於黏膜推進皮瓣的報導顯示，復發率在 13% 至 38% 之間。據報導，14、15、16、17、18 纖維蛋白膠注射與 40% 至 84% 的復發率相關，通常取決於隨訪時間的長短。19， 20， 21 在一些系列研究中，肛瘺栓的復發率為 57% 至 76%。22， 23 當鬆散插入時，seton 能夠進行束標記，刺激纖維化，並允許肛周敗血症從瘺管中短期和長期引流。它們可以緊密地系在一起，以允許封閉的括約肌機構緩慢、受控地分裂，同時將橫斷末端的分離降至最低。24， 25， 26 然而，後者也已知會導致嚴重的尿失禁。我們認為，我們的低復發率可能與膿毒症的初步充分引流有關，從而允許在掛線成熟后 6 個月內在相對更有利的組織癒合環境中進行確定性手術。在許多情況下，對道的錯誤識別，即使是毫米級的識別，也可能導致復發。 因此，我們認為我們的政策是針對持續性或復發性瘺管修改掛線，並在翻修後至少等待 6 個月，這有助於確保掛線已封閉正確的束，以便準確指導確定性手術。儘管長期 seton 可能會通過括約肌的一部分遷移，並可能通過將瘺管從複雜轉變為簡單來改善瘺管的構型，但正如我們在 6 個月時的 EAUS 所證明的那樣，在我們的研究中似乎並非如此。

There were no differences in incontinence scores between the 2 groups, although theoretically the LIFT procedure is less likely to compromise anal sphincter function. It is known that internal anal sphincter fragmentation can occur with transanal procedures.27, 28, 29, 30 In this study our incontinence rates after the ARAF procedure were consistent with our previous experience.³¹ It is likely that the preservation of anal function is related to the careful minimal opening of the anal dilators for only the limited periods of time required for the procedure.²⁷
兩組之間的尿失禁評分沒有差異，儘管理論上 LIFT 手術不太可能損害肛門括約肌功能。眾所周知，經肛門手術可發生肛門內括約肌碎裂。27， 28， 29， 30 在這項研究中，我們在 ARAF 手術後的失禁率與我們以前的經驗一致。³¹ 肛門功能的保留很可能與僅在手術所需的有限時間內小心翼翼地最小地打開肛門擴張器有關。²⁷

In 2007, when this study was designed, the ARAF literature reported recurrence rates of up to 63% (range, 17.6%–63%).6, 7, 8 Rojanasakul et al¹ reported a favorable outcome for LIFT, leading us to expect a better success rate. However, because the success rates of both arms of this study were greater than 92%, we concluded that the difference between the 2 procedures is that LIFT is technically easier and faster to perform than ARAF and results in greater quality of life for the patient. The lower recurrence rate for the ARAF procedure in our hands may be owing to the preliminary seton drainage to adequately drain the sepsis such that our repair was not compromised, however, this remains to be tested in a future study.
2007 年，當這項研究被設計時，ARAF 文獻報告的復發率高達 63% （範圍，17.6%-63%）。6， 7， 8 Rojanasakul 等人 ¹ 報告了 LIFT 的良好結果，使我們預期成功率會更高。然而，由於這項研究兩組的成功率都大於 92%，我們得出結論，這兩種手術之間的區別在於 LIFT 在技術上比 ARAF 更容易、更快速地執行，併為患者帶來更高的生活品質。我們手中 ARAF 手術的復發率較低可能是由於初步的掛線引流以充分引流膿毒症，從而不會影響我們的修復，但是，這仍有待在未來的研究中進行測試。

The major limitation of the study was the relatively small number of patients, but this was because complex fistula-in-ano are uncommon outside the context of a multicenter study. Therefore, patients were randomized on a 2:1 intervention versus control basis, as explained earlier in the Methods section. It is recognized that recurrence, particularly in complex anorectal fistulas, is dependent on time of follow-up evaluation. Although the gold standard for healing is considered imaging such as MRI or EAUS, it was not undertaken routinely because these investigations are not refundable by the Australian health care system and asymptomatic, postoperative patients who are feeling well are very hesitant to incur this additional financial burden. Nonetheless, it is known that recurrences are most common more than 4 months postoperatively.³² Our mean follow-up period of 20 months exceeds both this common recommendation and the length of reporting of most studies, although we cannot exclude the unusual very late recurrence specific to new procedures.
該研究的主要局限性是患者數量相對較少，但這是因為複雜肛瘺在多中心研究之外並不常見。因此，患者在 2：1 干預與對照的基礎上被隨機分配，如前面的方法部分所述。眾所周知，復發，尤其是複雜性肛門直腸瘺，取決於隨訪評估的時間。儘管癒合的黃金標準被認為是 MRI 或 EAUS 等影像學檢查，但它並不是常規進行的，因為這些檢查不能由澳大利亞醫療保健系統退還，並且感覺良好的無癥狀術後患者非常不願承擔這種額外的經濟負擔。儘管如此，眾所周知，術后 4 個月以上的復發最常見。³² 我們的平均隨訪期為 20 個月，超過了這一普遍建議和大多數研究的報告長度，儘管我們不能排除新手術特有的不尋常的極晚期復發。

There was no significant difference in recurrence rates between the LIFT and ARAF procedures. This randomized study of LIFT includes the management of complex fistula-in-ano. The study supports LIFT as a simple and safe treatment option in the management of trans-sphincteric fistula. This procedure can be performed quickly and results in a better quality of life for the patient. Initial seton drainage may have contributed to our favorable early midterm results with low recurrence rates after both LIFT and ARAF. Further research to determine whether the extended preliminary seton drainage increases rates of success for both techniques would be helpful. We hope to have stimulated interest for multicenter randomized controlled trials with larger numbers and long-term follow-up evaluation to confirm our results.
LIFT 和 ARAF 手術之間的復發率沒有顯著差異。這項 LIFT 隨機研究包括複雜性肛瘺的管理。該研究支援 LIFT 作為管理經括約肌瘺的一種簡單且安全的治療選擇。該程式可以快速執行，併為患者帶來更好的生活品質。初始掛線引流可能有助於我們良好的早期中期結果，LIFT 和 ARAF 後的復發率都較低。進一步研究以確定擴展的初步 seton 引流是否能提高兩種技術的成功率會有所説明。我們希望激發人們對更多病例和長期隨訪評估的多中心隨機對照試驗的興趣，以確認我們的結果。