Madbouly Khaled M, El Shazly Walid, Abbas Khaled S, Hussein Ahmed M
Department of Surgery, University of Alexandria, Alexandria, Egypt.
Dis Colon Rectum. 2014 Oct;57(10):1202-8. doi: 10.1097/DCR.0000000000000194.
The aim of this study was to compare the ligation of the intersphincteric fistula track with the mucosal advancement flap in the treatment of high transsphincteric anal fistulas.
This was a prospective randomized study performed at academic medical centers.
Patients with transsphincteric anal fistulas involving the upper part of anal sphincter were included.
Patients were randomly assigned to either ligation of intersphincteric fistula track or mucosal advancement flap.
The primary end points of the study were fistula closure, recurrence within 1 year, and continence by using the Wexner score. Secondary end points were morbidity, postoperative pain with the use of the visual analog scale, and quality of life with the use of the Cleveland Global Quality of Life score.
There were 70 patients (35 in each group). Mean age was 36.1 years in patients undergoing ligation of the intersphincteric fistula track vs 32.9 years in patients undergoing mucosal advancement flap (p = 0.33). Mean visual analog scale after 1 week was significantly higher in the mucosal advancement flap group than in the ligation of intersphincteric fistula track group (3.1 vs 4.8, p = 0.04), but no significant difference was found after 4 weeks. Primary healing was achieved in 33 patients undergoing ligation of the intersphincteric fistula track vs 32 patients undergoing mucosal advancement flap (p = 0.99). Mean healing time was 22.6 days in the ligation of intersphincteric fistula track group vs 32.1 days in mucosal advancement flap group (p = 0.01). After 1 year of follow-up, successful outcome was achieved in 26 patients (74.3%) undergoing ligation of intersphincteric fistula track and in 20 patients (65.7%) undergoing mucosal advancement flap (p = 0.58). No significant change in Wexner score occurred 4 weeks postoperatively. There was no significant difference between groups regarding Cleveland Global Quality of Life score (p = 0.5 and 0.07 after 4 and 12 weeks).
The short-term follow-up is a probable limitation. Although the sample size was calculated to detect difference with 80% power at a significance level of 5%, the negative result within this relatively small number of patients might have resulted from type II statistical error.
In patients with high transsphincteric anal fistulas, both ligation of intersphincteric fistula track procedure and mucosal advancement flap have a similar long-term healing rate, recurrences, continence, and quality of life. However, ligation of the intersphincteric fistula track has the advantage of less postoperative pain.
本研究旨在比较括约肌间瘘管结扎术与黏膜推进皮瓣术治疗高位经括约肌型肛瘘的效果。
这是一项在学术医疗中心进行的前瞻性随机研究。
纳入经括约肌型肛瘘累及肛门括约肌上部的患者。
患者被随机分配至括约肌间瘘管结扎术组或黏膜推进皮瓣术组。
本研究的主要终点为肛瘘闭合、1年内复发情况以及采用韦克斯纳评分评估的控便能力。次要终点为发病率、使用视觉模拟量表评估术后疼痛情况以及使用克利夫兰全球生活质量评分评估生活质量。
共70例患者（每组35例）。接受括约肌间瘘管结扎术的患者平均年龄为36.1岁，而接受黏膜推进皮瓣术的患者平均年龄为32.9岁（p = 0.33）。黏膜推进皮瓣术组术后1周的平均视觉模拟量表评分显著高于括约肌间瘘管结扎术组（3.1对4.8，p = 0.04），但4周后未发现显著差异。接受括约肌间瘘管结扎术的33例患者与接受黏膜推进皮瓣术的32例患者实现一期愈合（p = 0.99）。括约肌间瘘管结扎术组的平均愈合时间为22.6天，黏膜推进皮瓣术组为32.1天（p = 0.01）。随访1年后，接受括约肌间瘘管结扎术的26例患者（74.3%）和接受黏膜推进皮瓣术的20例患者（65.7%）取得了成功结局（p = 0.58）。术后4周韦克斯纳评分无显著变化。两组在克利夫兰全球生活质量评分方面无显著差异（术后4周和12周时p分别为0.5和0.07）。
短期随访可能是一个局限性。尽管样本量经计算可在5%的显著性水平下以80%的检验效能检测差异，但在这相对较少的患者数量中出现的阴性结果可能是由于II型统计错误导致的。
对于高位经括约肌型肛瘘患者，括约肌间瘘管结扎术和黏膜推进皮瓣术在长期愈合率、复发率、控便能力和生活质量方面相似。然而，括约肌间瘘管结扎术具有术后疼痛较轻的优势。
