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Observational Study Comparing Gastric Calibration Tubes

Sponsor
AZ Sint-Jan AV (Other)
Overall Status
Unknown status
CT.gov ID
NCT04170400
Collaborator
(none)
100
Enrollment
1
Location
12
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Observational Study Comparing Thin Pvc With Thick Silicone Gastric Calibration Tube for Bariatric Surgery
    Anticipated Study Start Date :
    Dec 1, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. need to change gastric tube [intraoperative]

      rate of changing gastric tube

    2. introduction time [intraoperative]

      time from start insertion till first staple in minutes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azsintjan Brugge Belgium 8000

    Sponsors and Collaborators

    • AZ Sint-Jan AV

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jan Mulier, Prof Dr, AZ Sint-Jan AV
    ClinicalTrials.gov Identifier:
    NCT04170400
    Other Study ID Numbers:
    • 2019OSgastrictube
    First Posted:
    Nov 20, 2019
    Last Update Posted:
    Nov 21, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 21, 2019