NCT04170322UnknownNot Applicable
Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- AZ Sint-Jan AV
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- introduction time
Study Overview
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
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •only primary sleeve gastrectomy
Exclusion Criteria
- •revision procedure
- •known eosophageal or gastric anatomical abnormalities
Outcomes
Primary Outcomes
introduction time
Time Frame: intraoperative
time from introduction until first staple in minutes
Secondary Outcomes
- rate of changing tube(intraoperative)
Investigators
Jan Mulier
Prof Dr
AZ Sint-Jan AV
Study Sites (2)
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