Effect of Anesthetic Conditions on Stapling Thickness and Quality

AZ Sint-Jan AV

Status: Unknown

Conditions: Gastrectomy

Treatments: Procedure: normal perfusion state; Procedure: low perfusion state

Study type: Interventional

Funder types: Other

Identifiers

NCT04191564

2020RCTStaplingcondition

Details and patient eligibility

About

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.

Full 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:

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

low perfusion

Experimental group

Description:

fluid restriction based on the goal directed fluid therapy is maintained during the whole case and a state of low perfusion is created by reducing the systolic blood pressure below 100 mmHg by vasoactive medications like cleviprex or nicardipine, by increasing positive end expiratory pressure (PEEP) and by a very short period of a high IAP of 20 mmHg only during firing.

Treatment:

Procedure: low perfusion state

normal perfusion

Experimental group

Description:

Perfusion pressure is maintained above 100 mmHg with free fluid loading iv and the lowest IAP possible during the whole procedure.

Treatment:

Procedure: normal perfusion state