title: [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].
abstract: OBJECTIVE
  To evaluate the effectiveness and safety of Ligation of the Intersphincteric Fistula Tract Plus Bioprosthetic Anal Fistula Plug (LIFT-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.
  
  
  CONCLUSIONS
  LIFT-plug is simple, less invasive, and with shorter healing time and more satisfactory healing rate in treating chronic anal fistula compared with LIFT.
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China; Email: wang3zj@sohu.com.
authors.forename: Zhenjun
authors.initials: Z
authors.lastname: Wang
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Xinqing
authors.initials: X
authors.lastname: Yang
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Jinjie
authors.initials: J
authors.lastname: Cui
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Chaowen
authors.initials: C
authors.lastname: Chen
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Xuebin
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Xiaoqiang
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Xiling
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Xiangming
authors.initials: X
authors.lastname: Che
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Jincai
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Feibo
authors.initials: F
authors.lastname: Cui
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Weiliang
authors.initials: W
authors.lastname: Song
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
authors.forename: Yuzhuo
authors.initials: Y
authors.lastname: Chen
mesh_terms: D005242:Fecal Incontinence; D005260:Female; D006801:Humans; D008026:Ligation; D008297:Male; D012003:Rectal Fistula; D012008:Recurrence; D014549:Urinary Incontinence; D014945:Wound Healing