Observational Study on Effect of Anesthetic Conditions on Stapling Thickness

Impact of Anesthetic Conditions on Stapling Quality Measured as Staple Thickness During Laparoscopic Sleeve Gastrectomy

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.

Study Overview

• Status: Unknown
• Conditions: Surgery
• Intervention / Treatment: Procedure: stapling

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Azsintjan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

obese patients undergoing bariatric surgery for the first time and where a sleeve gastrectomy is performed.

Description

Inclusion Criteria:

• primary sleeve gastrectomy

Exclusion Criteria:

• stomach disease
• prior surgery on the stomach

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thickness of staple line	thickness of staple line measured in micrometers	intra operative on excised stomach before being discarded

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Jan Paul Mulier, AZSint Jan AV

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020OSstaplingcondition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No