title: No rectopexy versus rectopexy following rectal mobilization for full-thickness rectal prolapse: a randomized controlled trial.
abstract: BACKGROUND
  No randomized controlled trial has compared no rectopexy with rectopexy for external full-thickness rectal prolapse.
  
  
  OBJECTIVE
  This study was performed to test the hypothesis that recurrence rates following no rectopexy are not inferior to those following rectopexy for full-thickness rectal prolapse.
  
  
  METHODS
  This was a multicenter randomized controlled trial. Eligible patients were randomly assigned to no rectopexy or rectopexy. The end point was recurrence rates defined as the presence of external full-thickness rectal prolapse after surgery. A prerandomized controlled trial meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves were generated and compared using the Kaplan-Meier method and log-rank test, respectively. Data were presented as median (range).
  
  
  METHODS
  This study was conducted in 41 tertiary centers in 21 countries.
  
  
  METHODS
  Patients with prior surgery for rectal prolapse or pelvic floor descent were not included.
  
  
  METHODS
  The no-rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and rectopexy. Sigmoid resection was not randomized and was added in the presence of constipation.
  
  
  METHODS
  Two hundred fifty-two patients with external full-thickness rectal prolapse were randomly assigned to undergo no rectopexy or rectopexy in 41 centers. All patients but one underwent the allocated intervention. One hundred sixteen no-rectopexy patients were comparable to 136 rectopexy patients for age (P = .21), body mass index (P = .61), ASA grade (P = .29), and previous abdominal surgery (P = .935), but not for sex (P = .013) and external full-thickness rectal prolapse length (8 (1-25) cm vs 5 (1-20) cm, P = .026). Sigmoid resection was performed more frequently in the no-rectopexy arm (P < .001). There was no significant difference in complication rates (11% vs 17.9%; P = .139). The mortality rate was 0.8%. The loss of patients to 5-year follow-up was 10.3%. Actuarial analysis demonstrated a significant difference in 5-year recurrence rates between study arms (8.6% vs 1.5%) (log-rank, P = .003).
  
  
  CONCLUSIONS
  Limitations were the high proportion of male patients, randomization timing, the lack of standardization for rectopexy technique, and the 10% loss to follow-up.
  
  
  CONCLUSIONS
  Recurrence rates following no rectopexy are inferior to those following rectopexy for external full-thickness rectal prolapse.
authors.affiliation: Division of Colon and Rectal Surgery, State University of New York, Stony Brook, New York, USA.
authors.forename: Joshua R
authors.initials: JR
authors.lastname: Karas
authors.forename: Selman
authors.initials: S
authors.lastname: Uranues
authors.forename: Donato F
authors.initials: DF
authors.lastname: Altomare
authors.forename: Selman
authors.initials: S
authors.lastname: Sokmen
authors.forename: Zoran
authors.initials: Z
authors.lastname: Krivokapic
authors.forename: Jiri
authors.initials: J
authors.lastname: Hoch
authors.forename: Ivan
authors.initials: I
authors.lastname: Bartha
authors.forename: Roberto
authors.initials: R
authors.lastname: Bergamaschi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D013505:Digestive System Surgical Procedures / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012005:Rectal Prolapse / Q000601:surgery*; D012008:Recurrence; D016896:Treatment Outcome