Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation
NCT ID: NCT01262417
Last Updated: 2010-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2008-07-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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- Seprafilm group
patients receiving resorbable barrier membrane during the first surgery
- 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
- No-treatment control group
patients without seprafilm barrier during the first surgery
without resorbable barrier (seprafilm)
non use of resorbable membrane during the first surgery for the resection of hepatic metastases
Interventions
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- 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
without resorbable barrier (seprafilm)
non use of resorbable membrane during the first surgery for the resection of hepatic metastases
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Centre Leon Berard
OTHER
Responsible Party
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Centre Léon Bérard, 28 rue Laënnec, 69373, Lyon
Principal Investigators
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Michel Rivoire, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Léon Bérard, Lyon
Locations
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Institut Bergonié
Bordeaux, , France
Hôpital Antoine Béclère
Clamart, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
Hôpital Beaujon
Clichy, , France
CHU Grenoble
Grenoble, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Centre Léon Bérard
Lyon, , France
Hôpital de La Croix Rousse
Lyon, , France
CHU La conception
Marseille, , France
Institut Paoli Calmettes
Marseille, , France
Centre Val d'Aurelle Paul Lamarque
Montpellier, , France
Centre Alexis Vautrin
Nancy, , France
Hôpital de Brabois CHU
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
Countries
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References
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Other Identifiers
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SEPRAC2T
Identifier Type: -
Identifier Source: org_study_id