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

全层直肠脱垂引起明显的不适。治疗通常是手术，描述了100多种方法。最重要的是会阴和经腹技术。目的是纠正直肠脱垂，恢复正常的肠道功能并避免复发。对于所有直肠脱垂患者，目前还不存在一种最佳的手术治疗方法。一般来说，会阴手术修复引起的发病率较低。特别适用于老年或高危患者。最常用的会阴入路是Delorme手术。会阴技术后复发似乎更频繁。腹腔镜切除直肠固定术与开放手术相比，术后早期效果更好，复发率相同。没有关于首选外科手术的有效证据。一个成功的前瞻性随机，充分的把握度试验比较这两个既定的手术技术从来没有完成。已发表的临床试验登记并未表明目前正在进行研究该问题的临床试验。本试验的目的主要是在2年随访期间比较Delorme手术与腹腔镜切除直肠固定术修复全层直肠脱垂后的复发时间。次要终点是5年随访期间全层直肠脱垂的复发时间和复发率。手术干预持续时间、发病率、死亡率、住院时间、复发性脱垂的再手术率、初次手术和随机化后24个月内因并发症或复发住院的累积住院时间、生活质量、便秘和失禁。

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.