Gastrectomy
Conditions
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:
Interventions
PROCEDURElow perfusion state
reduce SAP below 100 mmHg
PROCEDUREnormal perfusion state
maintain SAP above 100 mmHg
Sponsors
AZ Sint-Jan AV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
normal perfusion
Intervention model description
low perfusion
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Contacts
Primary ContactJan Paul Mulier, PhD
Backup Contactjan Mulier
Outcome results
None listed