跳至主要内容
临床试验/NCT04170322
NCT04170322Unknown不适用

Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.

AZ Sint-Jan AV2 个研究点 分布在 1 个国家目标入组 100 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
100
试验地点
2
主要终点
introduction time

研究概览

简要总结

Time from 40 Fr gastric calibration tube introduction on surgical request till first stapling is measured as introduction time.

Problems to advance are noted A note is made If change to other type of gastric tube is needed

详细描述

when ready to perform sleeve gastrectomy anesthesiologist is asked to introduce 40 Fr gastric calibration tube. A clock is running till first staple is fired as a measure of time to introduce.

If problems to position 40 Fr gastric calibration tube correctly, if resistance to advance, change to other type of gastric tube and check again difficulties. Make a note of problems and reason to change.

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
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • only primary sleeve gastrectomy

排除标准

  • revision procedure
  • known eosophageal or gastric anatomical abnormalities

结局指标

主要结局

introduction time

时间窗: intraoperative

time from introduction until first staple in minutes

次要结局

  • rate of changing tube(intraoperative)

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 (2)

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