Evaluationof the Efficiency of a Resorbable Barrier Membrane for the Prevention of Abdominal and Peri-hepatic Adhesion in Patients With Colorectal Cancer Requiring Two-stage Surgery for the Resection of Hepatic Metastases
The secondary objectives of the study are:
During and after the 1st surgical procedure To evaluate immediate complications (during
surgery), early complications (during post-surgery hospitalization) and late complications
(between 1st and 2nd surgeries) in relation with operating procedure and use of resorbable
During and after the 2nd surgical procedure
- To evaluate abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with
qualitative and quantitative description.
- To evaluate intestinal adhesion (in the small intestine), with quantitative
- To evaluate immediate complications (during surgery), early complications (during
post-surgery hospitalization) and late complications (in the month following the
intervention) in relation with operating procedure.
- To evaluate post-operative rehabilitation
- To assess tumour evolution in patients over a period of 3 years after the 2nd surgery.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
abdominal and peri-hepatic adhesion during the second operation
Time to liberate liver (t0: incision and t1: liberation)
Michel Rivoire, MD
Centre Léon Bérard, Lyon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)