Observational Study on Effect of Anesthetic Conditions on Stapling Thickness

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04172545
• Other study ID #: 2020OSstaplingcondition
• Status: Not yet recruiting
• 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 PhD
• Phone: +3250452490
• Email: jan.mulier[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• 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:

• primary sleeve gastrectomy

Exclusion Criteria:

• stomach disease

• prior surgery on the stomach

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• stapling
staples are fired through the gastric wall after waiting several seconds for compression without attention to blood pressure, fluids given or intra abdominal pressure, but these might have an impact on quality of stapling. therefore the conditions during stapling will be recorded during stapling.

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