Status:
COMPLETED
Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-stag...
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01262417
Start Date
July 1 2008
Last Update
December 17 2010
Active Locations (17)
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1
Institut Bergonié
Bordeaux, France, 33076
2
Hôpital Antoine Béclère
Clamart, France
3
CHU Clermont Ferrand
Clermont-Ferrand, France
4
Hôpital Beaujon
Clichy, France