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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04191564
Other study ID # 2020RCTStaplingcondition
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2020
Est. completion date December 2021

Study information

Verified date December 2019
Source AZ Sint-Jan AV
Contact Jan Paul Mulier, PhD
Phone 003259452490
Email jan.mulier@azsintjan.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the excluded stomach during sleeve gastrectomy can be investigated post removal outside the patient. During stapling it is common to reduce systolic arterial blood pressure (SAP) below 100 mmHg to reduce peritoneal perfusion and have better compression. Higher intra abdominal pressures reduce also the peritoneal and mucosal perfusion and might help to improve stapling compression. Stapling compression can be evaluated by measuring stapling thickness and compare it with stomach wall thickness or by measuring leaks during leak test or better outside the patient on the excised stomach with a bursting pressure.


Description:

Patients are randomized to two groups: group standard perfusion means that the SAP is kept between 100 and 140 mmHg by adapting depth of anesthesia, by level of post expiratory pressure or by giving vasoconstriction.

low perfusion group means that

1. systolic blood pressure is kept below 100 mmHg from the first linear staple till the last by using a Clevidipine infusion to regulate the blood pressure accurate just below 100 mmHg for a short time while needed.

2. goal directed fluid therapy using 100 ml/h fluid intravenous and extra load of fluid if pulse pressure variation > 20 %

3. increase intra abdominal pressure (IAP) up to 20 mmHg inly during stapling and return to minimum IAP needed to achieve 3 liter workspace.

The resected stomach is removed and analyzed outside the body before throwing away:


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
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:

- allergy to one of the drugs used intra operative

- liver, renal, cardiac or lung disease with limited function

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
low perfusion state
reduce SAP below 100 mmHg
normal perfusion state
maintain SAP above 100 mmHg

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 staple thickness in mm each staple is measured with thickness monitor on excised stomach before being discarded within 1 hour after surgery
Primary stomach thickness in mm close to staple measurement with a constant pressure thickness is measured every 10 seconds till 1 minute on excised stomach before being discarded within 1 hour after surgery
Primary bursting pressure in mmHg excised stomach is inflated with air under water with increasing pressure that is recorded. At moment of first bubbles intra gastric pressure is recorded on excised stomach before being discarded within 1 hour after surgery
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