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Trial record 65 of 1013 for:    colon cancer AND resection

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

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ClinicalTrials.gov Identifier: NCT01262417
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : December 17, 2010
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Leon Berard

Tracking Information
First Submitted Date  ICMJE December 15, 2010
First Posted Date  ICMJE December 17, 2010
Last Update Posted Date December 17, 2010
Study Start Date  ICMJE July 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
abdominal and peri-hepatic adhesion during the second operation [ Time Frame: Time to liberate liver (t0: incision and t1: liberation) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
  • immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane [ Time Frame: during the surgery ]
  • early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane [ Time Frame: during post-surgery hospitalization ]
  • 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) ]
  • 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 ]
  • intestinal adhesion (in the small intestine), with quantitative description [ Time Frame: at the beginning of the second surgical procedure ]
  • immediate complications in relation with operating procedure. [ Time Frame: during the 2nd surgical procedure ]
  • early complications (after 2ng operation) in relation with operating procedure. [ Time Frame: during post-surgery hospitalization ]
  • late complications in relation with operating procedure. [ Time Frame: in the month following the 2nd intervention ]
  • post-operative rehabilitation [ Time Frame: during post-surgery hospitalization ]
  • tumour evolution in patients [ Time Frame: over a period of 3 years after the 2nd surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: - Seprafilm group
    patients receiving resorbable barrier membrane during the first surgery
    Intervention: Procedure: - use of resorbable membrane Seprafilm
  • - No-treatment control group
    patients without seprafilm barrier during the first surgery
    Intervention: Procedure: without resorbable barrier (seprafilm)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2010)
60
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262417
Other Study ID Numbers  ICMJE SEPRAC2T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zora ABDELBOST, Centre Léon Bérard, 28 rue Laënnec, 69373, Lyon
Study Sponsor  ICMJE Centre Leon Berard
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Michel Rivoire, MD Centre Léon Bérard, Lyon
PRS Account Centre Leon Berard
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP