NCT01262417

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	- use of resorbable membrane Seprafilm	use of resorbable membrane during the first surgery for the resection of hepatic metastases, 1 to 4 membranes should be used around the liver
PROCEDURE	without resorbable barrier (seprafilm)	non use of resorbable membrane during the first surgery for the resection of hepatic metastases

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-11-01
• First posted: 2010-12-17
• Last updated: 2010-12-17

Locations

17 sites across 1 country: France