Observational Study Comparing Gastric Calibration Tubes

• Conditions: Surgery

• Registration Number: NCT04170400
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

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.

Detailed Description

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 ...

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-21
• Study Start: 2019-12
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
introduction time	intraoperative	time from start insertion till first staple in minutes
need to change gastric tube	intraoperative	rate of changing gastric tube

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium