改良括约肌间瘘管结扎术治疗慢性肛瘘的随机对照多中心临床观察

A multicenter randomized controlled clinical trial of Ligation of the Intersphincteric Fistula Tract Plus Bioprosthetic Anal Fistula Plug in the treatment of chronic anal fistula

目的 评价改良括约肌间瘘管结扎术（LIFT-plug）术式在慢性肛瘘治疗中的有效性及安全性.方法 选择2011年3月至2013年4月首都医科大学附属北京朝阳医院等5家医院收治的239例慢性肛瘘患者,其中男199例（83.26％）,女40例（16.74％）,对照表随机分配入试验组（脱细胞黏膜组）或对照组（单纯手术组）,试验组和对照组分别完成入组病例1 19例和120例,试验组采用LIFT-plug术式,对照组采用保留括约肌手术（UFT）术式,术后随访180 d.统计术后180 d内的治愈率和中位愈合时间,评估术后复发率、术后疼痛、肛门失禁率及材料安全相关.本研究得到北京朝阳医院伦理委员会批准,患者均签署知情同意书.结果 术后第180天脱细胞黏膜组愈合率为96.5％,单纯手术组愈合率为83.7％,脱细胞黏膜组中位术后愈合时间为22 d,单纯手术组中位术后愈合时间为30 d,组间术后愈合率和中位愈合时间差异有统计学意义.本次试验随访180 d期间无复发.术后标准数字评分法（VAS）疼痛评分术后第2、3天差异有统计学意义,其余随访时间VAS评分差异均无统计学意义.术后肛门失禁评分差异无统计学意义,均未发生严重的肛门失禁,试验组未发生与研究器械有关的不良事件.结论 LIFT-plug术式较之LIFT术式愈合率高,愈合时间短,组织损伤程度小,无肛门失禁发生,操作简单,是一种针对经慢性肛瘘更理想的方法.

Objective To evaluate the effectiveness and safety of Ligation of the Intersphincteric Fistula Tract Plus Bioprosthetic Anal Fistula Plug （LIFF-plug） in the treatment of chronic anal fistula.Methods A total of 239 patients （199 males,40 females） with chronic anal fistula were recruited from 5 hospitals between March 2011 and April 2013.These patients were randomly assigned to the experimental group （n =119） treated with LIFT-plug or the control group （n =120） treated with LIFT.The follow-up period was 180 days.The collected data included healing rate,the median healing time,the recurrence rate,the Visual Analogue Scale （VAS）,the incontinence rate,and the safety indicators associated with the anal fistula plug.Results The healing rate of the experimental group was better than the control group （96.5% vs 83.7%,P 〈0.05）.The median healing time of the experimental group was 22 days and the latter was 30 days （P 〈 0.05）.By the end of the follow-up period,there was no recurrence found in the two groups The VAS and the incontinence rate had no statistically significant difference between the two groups.There were no adverse events associated with the anal fistula plug in the experimental group.Conclusion LIFT-plug is simple,less invasive,and with shorter healing time and more satisfactory healing rate in treating chronic anal fistula compared with LIFT.