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

比较直肠脱垂的两种标准化手术方法的随机试验 - Delorme 手术与腹腔镜切除直肠固定术 (DeloRes)

• 批准号: 130241905
• 负责人: Professor Dr. Stefan Post
• 金额: --
• 依托单位: Chirurgische Klinik
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2010
• 资助国家: 德国
• 起止时间: 2009-12-31 至 2014-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/130241905?language=en
• 关键词: Randomized; trial; compare; two; standardized

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.

直肠全层脱垂会引起明显的不适。治疗通常是手术治疗，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，恢复正常肠道功能并避免复发。对于所有直肠脱垂患者来说，尚不存在最佳的手术治疗方法。一般来说，会阴手术修复的发病率较低。它们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。与具有相同复发率的开放手术相比，腹腔镜切除直肠固定术在术后早期可产生更好的效果。没有关于首选手术程序的有效证据。一项比较这两种既定手术技术的成功的前瞻性随机、动力充足的试验尚未完成。已公布的试验登记册并未表明目前正在进行一项调查该问题的试验。该试验的目的主要是在 2 年随访期间比较 Delorme 手术修复全层直肠脱垂与腹腔镜直肠切除术修复后的复发时间。次要终点是 5 年内全层直肠脱垂复发的时间和发生率 随访、手术干预持续时间、发病率、死亡率、住院时间、复发性脱垂再手术率、初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情况、生活质量、便秘和失禁。