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临床试验/NCT04170400
NCT04170400Unknown不适用

Observational Study Comparing Thin Pvc With Thick Silicone Gastric Calibration Tube for Bariatric Surgery

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12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
1
主要终点
introduction time

研究概览

简要总结

Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

详细描述

Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

A note is made of the problem encountered, how long it took to place it correctly ( time from insertion till first staple), what was done to solve the problem, if a new identical tube was used or another and what type was used. If another tube how log did it take to get first stapler done.

some demographic and procedure information is recorded: gender, age, BMI, procedure planned, first bariatric procedure or second after ...

研究设计

研究类型
Observational
观察模型
Case Only
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

  • bariatric surgery being sleeve gastrectomy, gastric bypass or conversion procedure.

排除标准

  • pre existing esophageal disease making use of gastric tube contra indicated, difficult or impossible.

结局指标

主要结局

introduction time

时间窗: intraoperative

time from start insertion till first staple in minutes

need to change gastric tube

时间窗: intraoperative

rate of changing gastric tube

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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