Laparoscopic Resection Rectopexy Versus Delorme's Procedure In Full-thickness Rectal Prolapse: A Randomized Multicenter Trial (DELORES-RCT).

Abstract

Objective: The DELORES trial investigated whether laparoscopic resection rectopexy (LRR) is superior to Delorme's procedure (DP) in full-thickness rectal prolapse.

Background: Multiple perineal and transabdominal procedures are current practice for rectal prolapse surgery. Evidence from adequately designed randomized studies addressing the question of which of these procedures are superior in terms of recurrence and bowel function is lacking.

Methods: DELORES was a randomized, observer-blinded, expertise-based multicenter trial. Patients with full-thickness rectal prolapse were eligible. The primary outcome was time to recurrence of full-thickness rectal prolapse within 24 months after primary surgery. The main secondary endpoints were morbidity, hospital stay, quality of life, constipation, and fecal incontinence (DRKS00000482).

Results: A total of 358 patients were screened between September 2010 and January 2016. Based on screening, 70 patients were randomized and 65 were included in the analysis (33 LRR and 32 DP procedures). The median follow-up was 23.9 months. Analysis of the primary outcome showed that LRR was superior to DP ( P =0.0012). During the 24-month follow-up, 8.2% of patients in the LRR group had a full-thickness prolapse recurrence versus 42.8% in the DP group. The median time to recurrence was 17.8 months for LRR and 8.2 months for DP. The median duration of surgery was 212 min (LRR) versus 77 min (DP). Overall postoperative morbidity was low. The reoperation rate was higher for DP (0% LRR vs. 33.3% DP). Quality of life (FIQL) and incontinence scores (Wexner) were more favorable for LRR at 24-month follow-up.

Conclusions: LRR is superior to DP in terms of recurrence and has favorable functional results.