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

直肠全层脱垂会引起明显的不适。治疗通常是外科手术，有超过100种方法被描述。最重要的是会阴和经腹技术。目的是矫正直肠脱垂，恢复正常的肠功能，避免复发。对于所有直肠脱垂患者，并不存在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。尤其适用于老年或高危患者。最常用的会阴入路是Delorme手术。会阴手术后复发似乎更频繁。在复发率相等的情况下，腹腔镜切除直肠固定术在术后早期比开放入路效果更好。目前还没有关于首选手术方法的有效证据。一项成功的前瞻性、随机、充分有力的比较这两种已建立的手术技术的试验从未完成。已公布的试验登记并未表明目前正在进行一项调查这一问题的试验。本试验的主要目的是比较Delorme手术修复全层直肠脱垂与腹腔镜直肠切除术后的复发时间，随访2年。次要终点是5年随访期间全层直肠脱垂的复发时间和发生率、手术干预时间、发病率、死亡率、住院时间、脱垂复发的再手术率、首次手术累积住院时间以及随机分组后24个月内因并发症或复发而住院的时间、生活质量、便秘和尿失禁。

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.