Effect of Anesthetic Conditions on Stapling Thickness and Quality

Not Applicable

• Conditions: Gastrectomy
• Interventions: Procedure: normal perfusion state; Procedure: low perfusion state

• Registration Number: NCT04191564
• Lead Sponsor: AZ Sint-Jan AV

Brief 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.

Detailed 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:

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-06
• Last Update Submitted: 2019-12-06
• Study First Posted: 2019-12-09
• Last Update Posted: 2019-12-09
• Study Start: 2020-03
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal perfusion	normal perfusion state	Perfusion pressure is maintained above 100 mmHg with free fluid loading iv and the lowest IAP possible during the whole procedure.
low perfusion	low perfusion state	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium