Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation

Overview

The purpose of this study is to evaluate 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. Eligible patients will be randomly assigned to one of 2 arms: * Seprafilm group (receiving resorbable barrier membrane during the first surgery) * No-treatment control group (without seprafilm barrier during the first surgery) The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation. This study is a prospective multicentric phase II, controlled, randomized and non comparative trial. A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.

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 membrane. 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 description. * 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.