Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

Surgery Clinical Trial

Official title:

Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04170322
• Other study ID #: 2019RCTgastrictube
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: AZ Sint-Jan AV
• Contact: Jan Paul Mulier, MD PhhD
• Phone: +3250452490
• Email: jan.mulier[@]azsintjan.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: only primary sleeve gastrectomy

-

Exclusion Criteria:

• revision procedure

• known eosophageal or gastric anatomical abnormalities

Related Conditions & MeSH terms

• Calibration Tube
• Surgery

Intervention

Device:
• thin pvc gastric tube
a thin pvc gastric tube of 40 Fr for sleeve is used to guide the surgeon
• thick silicone gastric tube
a thick silicone gastric tube 40 Fr for sleeve is used to guide the surgeon

Locations

Country	Name	City	State
Belgium	Azsintjan	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	introduction time	time from introduction until first staple in minutes	intraoperative
Secondary	rate of changing tube	Impossible for correct positioning requiring change to another tube	intraoperative