Effect of Anesthetic Conditions on Stapling Thickness and Quality

NCT04191564 | Unknown

• 1 other identifier: 2020RCTStaplingcondition
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrectomy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

low perfusion

EXPERIMENTAL

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

normal perfusion

EXPERIMENTAL

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

Interventions

low perfusion state PROCEDURE

reduce SAP below 100 mmHg

low perfusion

normal perfusion state PROCEDURE

maintain SAP above 100 mmHg

normal perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary sleeve gastrectomy

You may not qualify if:

• allergy to one of the drugs used intra operative
• liver, renal, cardiac or lung disease with limited function

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

Study Officials

• Jan Paul Mulier

  AZSint Jan AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Paul Mulier, PhD

CONTACT

003259452490; jan.mulier@azsintjan.be

jan Mulier

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: normal perfusion
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: low perfusion

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 9, 2019
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)