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

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Women and men aged ≥ 18 years
* Colorectal cancer with synchronous or metachronous hepatic metastases
* Patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases
* The 2 operations should be scheduled in the same centre
* The 2 operations should be scheduled at an interval of 1 to 6 months
* Patient affiliated with social security
* Patient able to read and write French
* Written, voluntary, informed consent

Exclusion Criteria:

* Patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously)
* Patient with previous major surgery except colorectal surgery for resection of primitive tumour
* Metastasis removable in one surgical procedure
* Non resectable metastasis
* Follow-up impossible for social, geographical, familial or psychological reasons
* Patient deprived of freedom
* Patient enrolled in another experimental surgery trial
* Pregnant or lactating woman

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