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Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

Sponsor
AZ Sint-Jan AV (Other)
Overall Status
Unknown status
CT.gov ID
NCT04170322
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: thin pvc gastric tube
  • Device: thick silicone gastric tube
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trialrandomized 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.
Anticipated Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. introduction time [intraoperative]

    time from introduction until first staple in minutes

Secondary Outcome Measures

  1. rate of changing tube [intraoperative]

    Impossible for correct positioning requiring change to another tube

Eligibility Criteria

Criteria

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

Inclusion Criteria: only primary sleeve gastrectomy

-

Exclusion Criteria:

  • revision procedure

  • known eosophageal or gastric anatomical abnormalities

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:
NCT04170322
Other Study ID Numbers:
  • 2019RCTgastrictube
First Posted:
Nov 20, 2019
Last Update Posted:
Mar 23, 2020
Last Verified:
Mar 1, 2020
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 Mar 23, 2020