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临床试验/NCT01595230
NCT01595230Unknown不适用

Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

Region Zealand4 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2012年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
405
试验地点
4
主要终点
To avoid the risk of Internal Hernias in patient with a Gastric bypass

研究概览

简要总结

The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who meet the requirements for a Gastric Bypass at Køge Hospital.

排除标准

  • Patients who do not meet the inclusion criteria
  • Patients who converted to open surgeon

结局指标

主要结局

To avoid the risk of Internal Hernias in patient with a Gastric bypass

时间窗: 5 year

次要结局

  • Operative time consumption, the amount of clips, trocar and sutures used(3 years)
  • Postoperative pain score (VAS)(5 years)

研究者

发起方
Region Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Kristensen

Doctor

Region Zealand

研究点 (4)

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