Trials / Unknown
UnknownNCT04191564
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- AZ Sint-Jan AV · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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:
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | low perfusion state | reduce SAP below 100 mmHg |
| PROCEDURE | normal perfusion state | maintain SAP above 100 mmHg |
Timeline
- Start date
- 2020-03-01
- Primary completion
- 2020-12-01
- Completion
- 2021-12-01
- First posted
- 2019-12-09
- Last updated
- 2019-12-09
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04191564. Inclusion in this directory is not an endorsement.