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

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 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.

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