Clinical trial NCT01262417: Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: colorectal cancer
two stage surgery for the resection of hepatic metastases
resorbable barrier membrane
abdominal and peri-hepatic adhesion
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2010-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: abdominal and peri-hepatic adhesion during the second operation
timeFrame: Time to liberate liver (t0: incision and t1: liberation)
Secondary outcomes:
measure: immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane
timeFrame: during the surgery
measure: early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane
timeFrame: during post-surgery hospitalization
measure: late complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane
timeFrame: between 1st and 2nd surgeries (2 operations should be scheduled at an interval of 1 to 6 months)
measure: abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description
timeFrame: at the beginning of the 2nd surgical procedure
measure: intestinal adhesion (in the small intestine), with quantitative description
timeFrame: at the beginning of the second surgical procedure
measure: immediate complications in relation with operating procedure.
timeFrame: during the 2nd surgical procedure
measure: early complications (after 2ng operation) in relation with operating procedure.
timeFrame: during post-surgery hospitalization
measure: late complications in relation with operating procedure.
timeFrame: in the month following the 2nd intervention
measure: post-operative rehabilitation
timeFrame: during post-surgery hospitalization
measure: tumour evolution in patients
timeFrame: over a period of 3 years after the 2nd surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Clichy
country: France
facility: Hôpital Beaujon
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
city: Marseille
country: France
facility: CHU La conception
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Centre Val d'Aurelle Paul Lamarque
city: Nancy
country: France
facility: Centre Alexis Vautrin
city: Nancy
country: France
facility: Hôpital de Brabois CHU
city: Nice
country: France
facility: CHU Nice-Hôpital de l'Archet II
city: Paris
country: France
facility: Hôpital Cochin
city: Rouen
country: France
facility: Hôpital Charles Nicolle - CHU Rouen
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Léon Bérard, Lyon
name: Michel Rivoire, MD
role: PRINCIPAL_INVESTIGATOR
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