Effect of Anesthetic Conditions on Stapling Thickness and Quality

Gastrectomy Clinical Trial

Official title:

Impact of Low Perfusion by High Intraabdominal Pressure and Low Blood Pressure on Stapling Quality Measured as Thickness Difference Between Staples and Stomach Wall and by Bursting Pressure of Excluded Stomach

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04191564
• Other study ID #: 2020RCTStaplingcondition
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gastrectomy

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