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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04172545
Enrollment
10
Registered
2019-11-21
Start date
2020-08-31
Completion date
2021-12-31
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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.

Interventions

PROCEDUREstapling

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.

Sponsors

AZ Sint-Jan AV
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* primary sleeve gastrectomy

Exclusion criteria

* stomach disease * prior surgery on the stomach

Design outcomes

Primary

MeasureTime frameDescription
thickness of staple lineintra operative on excised stomach before being discardedthickness of staple line measured in micrometers

Countries

Belgium

Contacts

Primary ContactJan Paul Mulier, MD PhD
jan.mulier@azsintjan.be+3250452490
Backup ContactMulier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026