Observational Study Comparing Gastric Calibration Tubes

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

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.

Study Overview

• Status: Unknown
• Conditions: Surgery

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: jan Mulier
• Study Contact Backup: Name: Jan Paul Mulier; Phone Number: +3250452490; Email: jan.mulier@azsintjan.be

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Azsintjan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient sheduled for bariatric surgery > 18 year sold and most of the time morbid obese. BMI > 35

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
need to change gastric tube	rate of changing gastric tube	intraoperative
introduction time	time from start insertion till first staple in minutes	intraoperative

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Jan Paul Mulier, AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019OSgastrictube

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No