NCT05658081招募中不适用
Stapled Antimesenteric Functional End-to-end Anastomosis (Kono-S) Versus Stapled Antimesenteric Isoperistaltic Side-to-side Anastomosis for the Postoperative Recurrence of Crohn's Disease: a Randomized Control Trial Study
Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2022年12月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- the endoscopic recurrence rate at 1 year after surgery
研究概览
简要总结
The postoperative recurrence of Crohn's diseases (CD) remains high. Stapled anti-mesenteric functional end-to-end anastomosis was safe for CD patients. Its impact on the postoperative recurrence of CD was unknown. Whether it is superior than the conventional anastomosis (stapled antimesenteric isoperistaltic side-to-side anastomosis) needs explored. The trial aims to compare the different impacts of the two antimesenteric anastomosis configurations on the anastomotic recurrence following bowel resection.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Crohn's disease needing bowel resection and anastomosis;
- •ileocolic anastomosis；
- •written consent acquired
排除标准
- •patients underwent enterostomy;
- •small bowel anastomosis;
- •anticipating other trial.
结局指标
主要结局
the endoscopic recurrence rate at 1 year after surgery
时间窗: at 1 year after surgery(6-18month)
the endoscopic recurrence rate at 1 year after surgery
次要结局
- the clinical recurrence rate at 1 and 5 year after surgery(1 and 5 year after surgery)
- quality of life for CD patients Short Form 12(1 and 5 year after surgery)
- the surgical recurrence rate at 1 and 5 year after surgery(1 and 5 year after surgery)
- quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)(1 and 5 year after surgery)
- the endoscopic recurrence rate at 1 year after surgery(1 and 5 year after surgery)
研究者
Zhu Weiming
Jinling Hospital
Jinling Hospital, China
研究点 (1)
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