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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01262417
First received: December 15, 2010
Last updated: December 16, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Colorectal Cancer
Procedure: - use of resorbable membrane Seprafilm
Procedure: without resorbable barrier (seprafilm)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • abdominal and peri-hepatic adhesion during the second operation [ Time Frame: Time to liberate liver (t0: incision and t1: liberation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane [ Time Frame: during the surgery ] [ Designated as safety issue: No ]
  • early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane [ Time Frame: during post-surgery hospitalization ] [ Designated as safety issue: No ]
  • late complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane [ Time Frame: between 1st and 2nd surgeries (2 operations should be scheduled at an interval of 1 to 6 months) ] [ Designated as safety issue: No ]
  • abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description [ Time Frame: at the beginning of the 2nd surgical procedure ] [ Designated as safety issue: No ]
  • intestinal adhesion (in the small intestine), with quantitative description [ Time Frame: at the beginning of the second surgical procedure ] [ Designated as safety issue: No ]
  • immediate complications in relation with operating procedure. [ Time Frame: during the 2nd surgical procedure ] [ Designated as safety issue: No ]
  • early complications (after 2ng operation) in relation with operating procedure. [ Time Frame: during post-surgery hospitalization ] [ Designated as safety issue: No ]
  • late complications in relation with operating procedure. [ Time Frame: in the month following the 2nd intervention ] [ Designated as safety issue: No ]
  • post-operative rehabilitation [ Time Frame: during post-surgery hospitalization ] [ Designated as safety issue: No ]
  • tumour evolution in patients [ Time Frame: over a period of 3 years after the 2nd surgery ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2008
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: use of Seprafilm after the resction of hepatic metastases
- 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 Name: resection of hepatic metastases

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262417

Locations
France
Institut Bergonié
Bordeaux, France, 33076
Hôpital Antoine Béclère
Clamart, France
CHU Clermont Ferrand
Clermont Ferrand, France
Hôpital Beaujon
Clichy, France
CHU Grenoble
Grenoble, France
Hôpital de La Croix Rousse
Lyon, France
Centre Léon Bérard
Lyon, France
Centre Hospitalier Lyon Sud
Lyon, France
Institut Paoli Calmettes
Marseille, France
CHU La conception
Marseille, France
Centre Val d'Aurelle Paul Lamarque
Montpellier, France
Hôpital de Brabois CHU
Nancy, France
Centre Alexis Vautrin
Nancy, France
CHU Nice-Hôpital de l'Archet II
Nice, France
Hôpital Cochin
Paris, France
Hôpital Charles Nicolle - CHU Rouen
Rouen, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Centre Leon Berard
Ministry of Health, France
Investigators
Principal Investigator: Michel Rivoire, MD Centre Léon Bérard, Lyon
  More Information

Publications:
Dixon WJ, Massey FJ. Introduction to statistical analysis. 4th Edition McGraw-Hill, 1983; 80-5.
Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zora ABDELBOST, Centre Léon Bérard, 28 rue Laënnec, 69373, Lyon
ClinicalTrials.gov Identifier: NCT01262417     History of Changes
Other Study ID Numbers: SEPRAC2T
Study First Received: December 15, 2010
Last Updated: December 16, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
colorectal cancer
two stage surgery for the resection of hepatic metastases
resorbable barrier membrane
abdominal and peri-hepatic adhesion

Additional relevant MeSH terms:
Tissue Adhesions
Colorectal Neoplasms
Cicatrix
Fibrosis
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 14, 2014