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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: - use of resorbable membrane Seprafilm
* Procedure: without resorbable barrier (seprafilm)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: - Seprafilm group<br>patients receiving resorbable barrier membrane during the first surgery | Procedure: - use of resorbable membrane Seprafilm<br>* use of resorbable membrane during the first surgery for the resection of hepatic metastases, 1 to 4 membranes should be used around the liver<br>* Other names: use of Seprafilm after the resction of hepatic metastases;|
| Other: - No-treatment control group<br>patients without seprafilm barrier during the first surgery | Procedure: without resorbable barrier (seprafilm)<br>* non use of resorbable membrane during the first surgery for the resection of hepatic metastases<br>* Other names: resection of hepatic metastases;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal and peri-hepatic adhesion during the second operation |  | Time to liberate liver (t0: incision and t1: liberation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane |  | during the surgery | 
| early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane |  | during post-surgery hospitalization | 
| late complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane |  | between 1st and 2nd surgeries (2 operations should be scheduled at an interval of 1 to 6 months) | 
| abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description |  | at the beginning of the 2nd surgical procedure | 
| intestinal adhesion (in the small intestine), with quantitative description |  | at the beginning of the second surgical procedure | 
| immediate complications in relation with operating procedure. |  | during the 2nd surgical procedure | 
| early complications (after 2ng operation) in relation with operating procedure. |  | during post-surgery hospitalization | 
| late complications in relation with operating procedure. |  | in the month following the 2nd intervention | 
| post-operative rehabilitation |  | during post-surgery hospitalization | 
| tumour evolution in patients |  | over a period of 3 years after the 2nd surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, two stage surgery for the resection of hepatic metastases, resorbable barrier membrane, abdominal and peri-hepatic adhesion