title: Ligation of Intersphincteric Fistula Tract vs Ligation of the Intersphincteric Fistula Tract Plus a Bioprosthetic Anal Fistula Plug Procedure in Patients With Transsphincteric Anal Fistula: Early Results of a Multicenter Prospective Randomized Trial.
abstract: OBJECTIVE
  The purpose of this study was to compare the ligation of intersphincteric fistula tract (LIFT) with an additional plug (LIFT-plug) in the treatment of transsphincteric anal fistula.
  
  
  BACKGROUND
  Both LIFT and LIFT-plug are recently reported effective alternatives of transsphincteric anal fistula.
  
  
  METHODS
  This multicenter prospective randomized study (NCT01478139) was conducted at 5 university hospitals throughout China. A total of 235 patients were randomly assigned to undergo LIFT (118 patients) or LIFT-plug (117 patients) between March 2011 and April 2013. The primary outcome measured was primary healing rate at 6 months postoperatively and healing time. Secondary outcomes included recurrence rate, postoperative pain, and incontinence rate.
  
  
  RESULTS
  The LIFT procedure showed shorter operative time than the LIFT-plug procedure (26.7 min vs 28.5 min, P = 0.03). Median healing time was 22 days in LIFT-plug group vs 30 days in LIFT group (P < 0.001). The difference in visual analog scale scores across all time points was not statistically significant between the groups (P = 0.13). The primary healing rate was higher in LIFT-plug group than in LIFT group [94.0% (95% confidence interval 89.7%-98.3%) vs 83.9% (95% confidence interval 77.2%-90.6%), P < 0.001]. There were no reported incontinence and recurrence within the follow-up period of 6 months.
  
  
  CONCLUSIONS
  In patients with transsphincteric anal fistulas, both LIFT-plug and LIFT are simple, safe, and effective procedures. LIFT-plug has the advantage of a higher healing rate, less healing time, and a lower early postoperative pain score.
authors.affiliation: *Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical Univerisity, Beijing, People's Republic of China†Department of General Surgery, Peking University Third Hosptial, Beijing, People's Republic of China‡Department of General Surgery, Shanxi Provincial People's Hospital, Shaanxi, People's Republic of China§Department of General Surgery, The First Affiliated Hospital of the School of Medicine Xi An Jiaotong University, Shaanxi, People's Republic of China¶Department of General Surgery, Tianjin Third Central Hospital, Tianjin, People's Republic of China.
authors.forename: Jia Gang
authors.initials: JG
authors.lastname: Han
authors.forename: Zhen Jun
authors.initials: ZJ
authors.lastname: Wang
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.forename: Chao Wen
authors.initials: CW
authors.lastname: Chen
authors.forename: Xiao Qiang
authors.initials: XQ
authors.lastname: Wang
authors.forename: Xiang Ming
authors.initials: XM
authors.lastname: Che
authors.forename: Wei Liang
authors.initials: WL
authors.lastname: Song
authors.forename: Jin Jie
authors.initials: JJ
authors.lastname: Cui
mesh_terms: D000328:Adult; D001705:Bioprosthesis; D002681:China; D005242:Fecal Incontinence / Q000453:epidemiology; D005260:Female; D006801:Humans; D008026:Ligation; D008297:Male; D061646:Operative Time; D010149:Postoperative Pain / Q000453:epidemiology; D011446:Prospective Studies; D012003:Rectal Fistula / Q000601:surgery*; D012008:Recurrence; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000453:epidemiology; D014945:Wound Healing