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
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
abdominal and peri-hepatic adhesion during the second operation
Outcome Time Frame:
Time to liberate liver (t0: incision and t1: liberation)
Safety Issue:
No
Principal Investigator
Michel Rivoire, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Léon Bérard, Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
SEPRAC2T
NCT ID:
NCT01262417
Start Date:
July 2008
Completion Date:
Related Keywords:
- Colorectal Cancer
- colorectal cancer
- two stage surgery for the resection of hepatic metastases
- resorbable barrier membrane
- abdominal and peri-hepatic adhesion
- Tissue Adhesions
- Colorectal Neoplasms
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