Observational Study on Effect of Anesthetic Conditions on Stapling Thickness

• Conditions: Surgery

• Registration Number: NCT04172545
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.

Detailed Description

During each staple firing the staple size, time of compression and anesthetic conditions being systolic arterial pressure, fluids transfused and intra abdominal pressure used are recorded.

After removal of stapled stomach during surgery, thickness of stomach wall and thickness of staple line are measured and compared to evaluate quality of staple formation.

the closer the staple height to the wall thickness the better the quality of stapling. Because no one has ever analyzed this relationship, and certainly not under different anesthetic conditions it is not clear yet if any relationship will be found.

the analysis will help to understand the relation and help to start perhaps a randomised trial to learn what conditions are best to improve staple quality.

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• 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: 10

Inclusion Criteria

• primary sleeve gastrectomy

Exclusion Criteria

• stomach disease
• prior surgery on the stomach

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thickness of staple line	intra operative on excised stomach before being discarded	thickness of staple line measured in micrometers

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium