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临床试验/NCT04172545
NCT04172545Unknown不适用

Impact of Anesthetic Conditions on Stapling Quality Measured as Staple Thickness During Laparoscopic Sleeve Gastrectomy

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
thickness of staple line

研究概览

简要总结

Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.

详细描述

During each staple firing the staple size, time of compression and anesthetic conditions being systolic arterial pressure, fluids transfused and intra abdominal pressure used are recorded.

After removal of stapled stomach during surgery, thickness of stomach wall and thickness of staple line are measured and compared to evaluate quality of staple formation.

the closer the staple height to the wall thickness the better the quality of stapling. Because no one has ever analyzed this relationship, and certainly not under different anesthetic conditions it is not clear yet if any relationship will be found.

the analysis will help to understand the relation and help to start perhaps a randomised trial to learn what conditions are best to improve staple quality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary sleeve gastrectomy

排除标准

  • stomach disease
  • prior surgery on the stomach

结局指标

主要结局

thickness of staple line

时间窗: intra operative on excised stomach before being discarded

thickness of staple line measured in micrometers

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

Jan Mulier

Prof Dr

AZ Sint-Jan AV

研究点 (1)

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