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. DESIGN: 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). SETTING: This study was conducted in 41 tertiary centers in 21 countries. PATIENTS: Patients with prior surgery for rectal prolapse or pelvic floor descent were not included. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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). LIMITATIONS: 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.
RCT Entities:
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. DESIGN: 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). SETTING: This study was conducted in 41 tertiary centers in 21 countries. PATIENTS: Patients with prior surgery for rectal prolapse or pelvic floor descent were not included. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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). LIMITATIONS: 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: G Gallo; J Martellucci; G Pellino; R Ghiselli; A Infantino; F Pucciani; M Trompetto Journal: Tech Coloproctol Date: 2018-12-15 Impact factor: 3.781