Partial liver resection complications Surgery Liver resection
Conditions
Interventions
Randomisation to treatment group will be performed using a sealed envelope and will be performed prior to peritoneal closure after completion of conventional hemostasis and bile stasis. Only the surg
Sponsors
Johnson and Johnson Medical Limited (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged greater than or equal to 18 years, either sex 2. Undergo liver resections (at least one segment) for benign or malignant tumours or metastatic tumours, or 3. Undergo liver resection in combination with radiofrequency ablation (RFA)
Exclusion criteria
Exclusion criteria: 1. Aged less than 18 years 2. Undergo liver resections with extrahepatic biliary resection and reconstruction (Klatskin tumours) 3. Cirrhosis 4. Other disorders of haemostasis 5. Polycystic liver disease 6. Any associated operative gastrointestinal procedures (a needle catheter jejunostomy is not excluded) 7. Wedge resections 8. Pregnancy 9. History of hypersensitivity, allergy or anaphylactic reaction to any plasma derived product, including fibrin sealant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Resection surface related complications detected by computed tomography (CT) scan or clinical symptoms: haematoma, biloma or subphrenic abscess 2. Diaphragm related complications detected by CT scan or clinical symptoms: pleural effusion 3. Need for reintervention for bleeding or bile leakage from the cut surface of the liver, or pleural effusion CT scan after 7 days, further assessment of complications and reinterventions during hospital stay until first out-patient appointment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in drain bilirubin (micromol/l), drain hemoglobin concentration (mmol/l) and volume of fluid drainage (ml) from the abdominal drains during the first three days post-operatively 2. Decrease in serum haemoglobin concentration (mmol/l) (lab day 1, 3, 5, 7, thereafter weekly) 3. Transfusion requirement (whole admission until first outpatient appointment) 4. Post-operative morbidity (whole admission until outpatient appointment) 5. Post-operative mortality (whole admission until outpatient appointment) 6. Length of hospital stay (whole admission until outpatient appointment) | — |
Countries
Netherlands
Outcome results
None listed