Effect of Anesthetic Conditions on Stapling Thickness and Quality

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastrectomy
• Intervention / Treatment: Procedure: low perfusion state; Procedure: normal perfusion state

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Paul Mulier, PhD; Phone Number: 003259452490; Email: jan.mulier@azsintjan.be
• Study Contact Backup: Name: jan Mulier

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Azsintjan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low perfusion; 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.	Procedure: low perfusion state; reduce SAP below 100 mmHg
Experimental: normal perfusion; Perfusion pressure is maintained above 100 mmHg with free fluid loading iv and the lowest IAP possible during the whole procedure.	Procedure: normal perfusion state; maintain SAP above 100 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
staple thickness in mm	each staple is measured with thickness monitor	on excised stomach before being discarded within 1 hour after surgery
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
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

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Jan Paul Mulier, AZSint Jan AV

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2020RCTStaplingcondition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No