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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
- use of resorbable membrane Seprafilm
without resorbable barrier (seprafilm)
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colorectal cancer, two stage surgery for the resection of hepatic metastases, resorbable barrier membrane, abdominal and peri-hepatic adhesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut Bergonié
  • Hôpital Antoine Béclère
  • CHU Clermont Ferrand
  • Hôpital Beaujon
  • CHU Grenoble
  • Centre Hospitalier Lyon Sud
  • Centre Léon Bérard
  • Hôpital de La Croix Rousse
  • CHU La conception
  • Institut Paoli Calmettes
  • Centre Val d'Aurelle Paul Lamarque
  • Centre Alexis Vautrin
  • Hôpital de Brabois CHU
  • CHU Nice-Hôpital de l'Archet II
  • Hôpital Cochin
  • Hôpital Charles Nicolle - CHU Rouen
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

- Seprafilm group

- No-treatment control group

Arm Description

patients receiving resorbable barrier membrane during the first surgery

patients without seprafilm barrier during the first surgery

Outcomes

Primary Outcome Measures

abdominal and peri-hepatic adhesion during the second operation

Secondary Outcome Measures

immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane
early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane
late complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane
abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description
intestinal adhesion (in the small intestine), with quantitative description
immediate complications in relation with operating procedure.
early complications (after 2ng operation) in relation with operating procedure.
late complications in relation with operating procedure.
post-operative rehabilitation
tumour evolution in patients

Full Information

First Posted
December 15, 2010
Last Updated
December 16, 2010
Sponsor
Centre Leon Berard
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01262417
Brief Title
Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation
Acronym
SEPRAC2T
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

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Leon Berard
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, two stage surgery for the resection of hepatic metastases, resorbable barrier membrane, abdominal and peri-hepatic adhesion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
- Seprafilm group
Arm Type
Experimental
Arm Description
patients receiving resorbable barrier membrane during the first surgery
Arm Title
- No-treatment control group
Arm Type
Other
Arm Description
patients without seprafilm barrier during the first surgery
Intervention Type
Procedure
Intervention Name(s)
- use of resorbable membrane Seprafilm
Other Intervention Name(s)
use of Seprafilm after the resction of hepatic metastases
Intervention Description
use of resorbable membrane during the first surgery for the resection of hepatic metastases, 1 to 4 membranes should be used around the liver
Intervention Type
Procedure
Intervention Name(s)
without resorbable barrier (seprafilm)
Other Intervention Name(s)
resection of hepatic metastases
Intervention Description
non use of resorbable membrane during the first surgery for the resection of hepatic metastases
Primary Outcome Measure Information:
Title
abdominal and peri-hepatic adhesion during the second operation
Time Frame
Time to liberate liver (t0: incision and t1: liberation)
Secondary Outcome Measure Information:
Title
immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane
Time Frame
during the surgery
Title
early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane
Time Frame
during post-surgery hospitalization
Title
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)
Title
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
Title
intestinal adhesion (in the small intestine), with quantitative description
Time Frame
at the beginning of the second surgical procedure
Title
immediate complications in relation with operating procedure.
Time Frame
during the 2nd surgical procedure
Title
early complications (after 2ng operation) in relation with operating procedure.
Time Frame
during post-surgery hospitalization
Title
late complications in relation with operating procedure.
Time Frame
in the month following the 2nd intervention
Title
post-operative rehabilitation
Time Frame
during post-surgery hospitalization
Title
tumour evolution in patients
Time Frame
over a period of 3 years after the 2nd surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Rivoire, MD
Organizational Affiliation
Centre Léon Bérard, Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Antoine Béclère
City
Clamart
Country
France
Facility Name
CHU Clermont Ferrand
City
Clermont Ferrand
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hôpital de La Croix Rousse
City
Lyon
Country
France
Facility Name
CHU La conception
City
Marseille
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Centre Val d'Aurelle Paul Lamarque
City
Montpellier
Country
France
Facility Name
Centre Alexis Vautrin
City
Nancy
Country
France
Facility Name
Hôpital de Brabois CHU
City
Nancy
Country
France
Facility Name
CHU Nice-Hôpital de l'Archet II
City
Nice
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
Hôpital Charles Nicolle - CHU Rouen
City
Rouen
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

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

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