Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

Not Applicable

• Conditions: Calibration Tube; Surgery
• Interventions: Device: thick silicone gastric tube; Device: thin pvc gastric tube

• Registration Number: NCT04170322
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-23
• Study Start: 2020-08
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

only primary sleeve gastrectomy

Exclusion Criteria

• revision procedure
• known eosophageal or gastric anatomical abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thick silicone gastric calibration tube	thick silicone gastric 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
thin pvc gasrtric calibration tube	thin pvc gastric 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.

Primary Outcome Measures

Name	Time	Method
introduction time	intraoperative	time from introduction until first staple in minutes

Secondary Outcome Measures

Name	Time	Method
rate of changing tube	intraoperative	Impossible for correct positioning requiring change to another tube

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium