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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized controlled trial|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
- introduction time [ Time Frame: intraoperative ]time from introduction until first staple in minutes
- rate of changing tube [ Time Frame: intraoperative ]Impossible for correct positioning requiring change to another tube
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
|Contact: Jan Paul Mulier, MD PhhDemail@example.com|
|Contact: jan Mulierfirstname.lastname@example.org|
|Brugge, Belgium, 8000|
|Principal Investigator:||Jan Paul Mulier||AZ Sint-Jan AV|