SEPRAC2T: Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation

Sponsor

Centre Leon Berard (Other)

Overall Status

Completed

CT.gov ID

NCT01262417

Collaborator

Ministry of Health, France (Other)

Enrollment

Locations

Arms

3.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Procedure: - use of resorbable membrane Seprafilm Procedure: without resorbable barrier (seprafilm)	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: - Seprafilm group patients receiving resorbable barrier membrane during the first surgery	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 Other Names: use of Seprafilm after the resction of hepatic metastases
Other: - No-treatment control group patients without seprafilm barrier during the first surgery	Procedure: without resorbable barrier (seprafilm) non use of resorbable membrane during the first surgery for the resection of hepatic metastases Other Names: resection of hepatic metastases

Arm

Intervention/Treatment

Experimental: - Seprafilm group

patients receiving resorbable barrier membrane during the first surgery

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

Other Names:

use of Seprafilm after the resction of hepatic metastases

Other: - No-treatment control group

patients without seprafilm barrier during the first surgery

Procedure: without resorbable barrier (seprafilm)

non use of resorbable membrane during the first surgery for the resection of hepatic metastases

Other Names:

resection of hepatic metastases

Outcome Measures

Primary Outcome Measures

abdominal and peri-hepatic adhesion during the second operation [Time to liberate liver (t0: incision and t1: liberation)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut Bergonié	Bordeaux	France	33076
2	Hôpital Antoine Béclère	Clamart	France
3	CHU Clermont Ferrand	Clermont Ferrand	France
4	Hôpital Beaujon	Clichy	France
5	CHU Grenoble	Grenoble	France
6	Centre Hospitalier Lyon Sud	Lyon	France
7	Centre Léon Bérard	Lyon	France
8	Hôpital de La Croix Rousse	Lyon	France
9	CHU La conception	Marseille	France
10	Institut Paoli Calmettes	Marseille	France
11	Centre Val d'Aurelle Paul Lamarque	Montpellier	France
12	Centre Alexis Vautrin	Nancy	France
13	Hôpital de Brabois CHU	Nancy	France
14	CHU Nice-Hôpital de l'Archet II	Nice	France
15	Hôpital Cochin	Paris	France
16	Hôpital Charles Nicolle - CHU Rouen	Rouen	France
17	Institut Gustave Roussy	Villejuif	France