The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Accumulated 5-year postoperative surgical recurrence
研究概览
简要总结
The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.
详细描述
EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.
EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection
- •Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria
排除标准
- •Pregnancy or willingness to become pregnant in the following year
- •Previous ileocolic resection history
- •Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon
- •Patients having an internal fistula which required resection of another segment of bowel
研究组 & 干预措施
Extensive mesenteric resection
Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
干预措施: Extensive mesenteric resection (Procedure)
Limited mesenteric excision
Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
干预措施: Limited mesenteric excision (Procedure)
结局指标
主要结局
Accumulated 5-year postoperative surgical recurrence
时间窗: 5 years after the first surgery
The requirement for repeat surgery for a Crohn's disease related indication.
次要结局
- Accumulated 5-year endoscopic recurrence(5 years after the first surgery)
- Accumulated 5-year clinical recurrence(5 years after the first surgery)
研究者
Weiming Zhu
Chief of general surgery
Jinling Hospital, China