Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- postoperative endoscopic recurrence
研究概览
简要总结
Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.
详细描述
Randomization was performed intraoperatively once the surgeon had determined that there were no other sites of disease and that either type of anastomosis could be performed safely. Computer generated randomization was carried out within strata using randomized permuted blocks to ensure balance of the groups.
All surgery was performed by a single group of surgeons experienced in the surgical treatment of Crohn's disease. Surgery was performed open or laparoscopically depending on patient factors and surgeon preference. The resection was performed grossly normal resection margins, with side-to-side anastomosis. The presence of mesenteric marginal thickening with confirmation by naked eye assessment of the mucosal aspect of the bowel were used to establish the limits of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's disease limited to the distal ileum and/or right colon
排除标准
- •Concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion
研究组 & 干预措施
LME
the anastomosis was performed as stapled side-to-side with local excision of the mesenteric tissue adjacent to the diseased bowel
干预措施: mesenteric excision (Procedure)
EME
the anastomosis was performed as a stapled side-to-side anastomosis with extensive excision of mesenteric tissue.
干预措施: mesenteric excision (Procedure)
结局指标
主要结局
postoperative endoscopic recurrence
时间窗: 12 months
次要结局
未报告次要终点
研究者
Zhu Weiming
Jinling Hospital
Jinling Hospital, China
