Ischemic Preconditioning at a Distance in Liver Surgery
Keywords
Abstract
Dates
Last Verified: | 10/31/2019 |
First Submitted: | 11/19/2019 |
Estimated Enrollment Submitted: | 11/26/2019 |
First Posted: | 11/28/2019 |
Last Update Submitted: | 11/26/2019 |
Last Update Posted: | 11/28/2019 |
Actual Study Start Date: | 01/31/2020 |
Estimated Primary Completion Date: | 01/31/2021 |
Estimated Study Completion Date: | 01/31/2021 |
Condition or disease
Intervention/treatment
Procedure: Inflation of a pneumatic tourniquet
Other: No inflation
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Inflation of a pneumatic tourniquet | Procedure: Inflation of a pneumatic tourniquet a pneumatic tourniquet around 200 mmHg after venous chase of the lower limb, during 5 minutes then deflated. Repeated twice after general anaesthesia and prior to incision. |
Sham Comparator: No inflation No inflation of the pneumatic tourniquet placed on the lower limb | Other: No inflation No inflation of the pneumatic tourniquet placed on the lower limb |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Scheduled carcinogenic laparoscopy or laparotomy liver resection - Insured under the social security system - Inclined to comply to the study protocol and its duration. Exclusion Criteria: - Patient under guardianship - Pregnancy or breastfeeding - Severe lower limb vascular disease - Emergency surgery - Contraindication of a treatment from the protocol - Psychological disorder with difficulty to accede the protocol - Absence of written informed consent - Refusal to sign the protocol - Non-registration to the social security system |
Outcome
Primary Outcome Measures
1. Indocyanine green clearance [at 5 days after liver resection]
Secondary Outcome Measures
1. Serum transaminases rates [at day 1,day 3 and day 5 post-hepatectomy.]
2. Prothrombin rate [at day 5 post-hepatectomy.]
3. the Kidney Disease: Improving Global Outcomes (KDIGO) score [at day 1,day 3 and day 5 post-hepatectomy.]
4. the Clavien & Dindo score [at day 30 post-hepatectomy]
5. duration of stay in the hospital. [at day 30 post-hepatectomy]