Randomized trial to compare two standardized surgical approaches in rectal prolapse - Delorme's procedure vs. laparoscopic resection rectopexy (DeloRes)

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Full-thickness prolapse of the rectum causes significant discomfort. Treatment is usually surgical, over 100 approaches are described. The most important are the perineal and transabdominal techniques.Aim is to correct rectal prolapse, to restore normal bowel function and to avoid recurrence. An optimal surgical treatment for all patients with rectal prolapse does not exist. In general, perineal surgical repairs cause less morbidity. They are especially indicated in elderly or high-risk patients. The most frequently used perineal approach is Delorme´s procedure. Recurrences seem more frequent after perineal techniques. Laparoscopic resection rectopexy is suggested to yield better results in the early postoperative phase compared to the open approach with equal recurrence rates. There is no valid evidence in regard to the preferred surgical procedure. A successful prospective randomized, adequately powered trial comparing these two established operation techniques has never been completed. The published trial registers do not indicate that there is currently an ongoing trial investigating this question.The aim of this trial is primarily to compare the time-to-recurrence after repair of full-thickness rectal prolapse by Delorme´s procedure versus laparoscopic resection rectopexy during a 2-year follow-up.Secondary endpoints are time to and incidence of recurrence of full-thickness rectal prolapse during 5- year follow-up, duration of surgical intervention, morbidity, mortality, length of hospital stay, reoperation rate for recurrent prolapse, cumulative hospital stay due to primary operation and following hospitalizations because of complications or recurrence within 24 months after randomization, quality of life, constipation and incontinence.