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Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

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ClinicalTrials.gov Identifier: NCT04170322
Recruitment Status : Not yet recruiting
First Posted : November 20, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jan Mulier, AZ Sint-Jan AV

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Surgery Calibration Tube Device: thin pvc gastric tube Device: thick silicone gastric tube Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. introduction time [ Time Frame: intraoperative ]
    time from introduction until first staple in minutes


Secondary Outcome Measures :
  1. rate of changing tube [ Time Frame: intraoperative ]
    Impossible for correct positioning requiring change to another tube



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: only primary sleeve gastrectomy

-

Exclusion Criteria:

  • revision procedure
  • known eosophageal or gastric anatomical abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170322


Contacts
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Contact: Jan Paul Mulier, MD PhhD +3250452490 jan.mulier@azsintjan.be
Contact: jan Mulier 003250452490 jan.mulier@azsintjan.be

Locations
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Belgium
Azsintjan
Brugge, Belgium, 8000
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Jan Paul Mulier AZ Sint-Jan AV

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Responsible Party: Jan Mulier, Prof Dr, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT04170322     History of Changes
Other Study ID Numbers: 2019RCTgastrictube
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No