Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of participants with endoscopic recurrence at 6 months
研究概览
简要总结
The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.
详细描述
The current standard of care for ileocolic Crohn's disease (CD) is a limited mesenteric resection. There is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. We propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic CD and how it affects disease recurrence. The primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic CD. Secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. These outcomes will be compared to historical controls (limited mesenteric resection). Our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. As seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults >18 years old
- •diagnosis of CD limited to the distal ileum/ileocolic region
- •no previous ileocolic resection
- •all forms of CD presentation will be included - stricturing, fistulizing, perforating etc.
排除标准
- •previous ileocolic resection
- •other sites of CD
- •intraabdominal sepsis
结局指标
主要结局
Number of participants with endoscopic recurrence at 6 months
时间窗: 6 months
Endoscopic recurrence after extended mesenteric ileocolic resection
次要结局
- Rates of post-operative complications compared between study groups(30 days)
- Number of participants with endoscopic recurrence at 18 months(18 months)
- Rates of recurrence requiring surgery by 2 years(24 months)
研究者
Sender Liberman MD
Dr. Sender Liberman, Associate Professor of Surgery and Oncology (McGill University), PI
Montreal General Hospital