Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

March 20, 2020 updated by: Jan Mulier, AZ Sint-Jan AV

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Azsintjan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: only primary sleeve gastrectomy

-

Exclusion Criteria:

  • revision procedure
  • known eosophageal or gastric anatomical abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: thin pvc gasrtric calibration tube
thin pvc gastric calibration tube is inserted after intubation to release gas from the stomach, then moved in correct position to help surgeon construct a sleeve gastrectomy.
Device: thin pvc gastric tube
a thin pvc gastric tube of 40 Fr for sleeve is used to guide the surgeon
Active Comparator: thick silicone gastric calibration tube
thick silicone gastrric calibration tube is inserted after intubation to release gas from the stomach, then moved in correct position to help surgeon construct a sleeve gastrectomy
Device: thick silicone gastric tube
a thick silicone gastric tube 40 Fr for sleeve is used to guide the surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
introduction time
Time Frame: intraoperative
time from introduction until first staple in minutes
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of changing tube
Time Frame: intraoperative
Impossible for correct positioning requiring change to another tube
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2019RCTgastrictube

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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