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临床试验/NCT02069626
NCT02069626Unknown不适用

The Effect of Compression Time for Secure Stapling With a Linear Stapler in Laparoscopic Gastric Bypass Surgery

Inonu University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Number of the bleeding points at the staple line

研究概览

简要总结

Bleeding from the staple line is a complication of linear stapling. After clamping, a short period after firing of the laparoscopic linear stapler is recommended. That is, the clinician should continue to press the tissue between the prongs of the device to achieve adequate hemostasis at the staple line. The significance of the waiting period for hemostasis at the staple line has not been empirically clarified in humans. In this study, the investigators compared the number of bleeding points use of the laparoscopic linear stapler. Consequently, the investigators assessed the effects of time after the firing of linear stapling in patients who underwent laparoscopic gastric bypass.

研究设计

研究类型
Interventional
分配方式
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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of morbid obesity
  • •Must be laparoscopic surgery

排除标准

  • •Usage of anti-coagulant
  • •Presence of impaired blood clotting

研究组 & 干预措施

No wait

Active Comparator

Usage of linear stapler without waiting of compression time

干预措施: compression time of the laparoscopic linear stapler (Procedure)

20 second wait

Active Comparator

Usage of linear stapler with 20 second compression time

干预措施: compression time of the laparoscopic linear stapler (Procedure)

60 second wait

Active Comparator

Usage of linear stapler with 60 second compression time

干预措施: compression time of the laparoscopic linear stapler (Procedure)

结局指标

主要结局

Number of the bleeding points at the staple line

时间窗: intraoperative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mehmet ali yagci

MD

Inonu University

研究点 (1)

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