Observational Study on Effect of Anesthetic Conditions on Stapling Thickness

NCT ID: NCT04172545

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primary sleeve gastrectomy

Exclusion Criteria

* stomach disease
* prior surgery on the stomach
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Jan Mulier

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Paul Mulier

Role: PRINCIPAL_INVESTIGATOR

AZSint Jan AV

Locations

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Azsintjan

Bruges, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Jan Paul Mulier, MD PhD

Role: CONTACT

+3250452490

Mulier

Role: CONTACT

Other Identifiers

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2020OSstaplingcondition

Identifier Type: -

Identifier Source: org_study_id

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