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临床试验/NCT02542904
NCT02542904已完成不适用

Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Active Comparator

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

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhu Weiming

Jinling Hospital

Jinling Hospital, China

研究点 (1)

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