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NCT Number: NCT01262417

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Bergonié, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

- use of resorbable membrane Seprafilm

Procedure

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 names: use of Seprafilm after the resction of hepatic metastases

without resorbable barrier (seprafilm)

Procedure

non use of resorbable membrane during the first surgery for the resection of hepatic metastases

Other names: resection of hepatic metastases

Primary outcomes

  1. abdominal and peri-hepatic adhesion during the second operation

    Time frame: Time to liberate liver (t0: incision and t1: liberation)

Secondary outcomes

  1. immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane

    Time frame: during the surgery

  2. early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane

    Time frame: during post-surgery hospitalization

  3. 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)

  4. 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

  5. intestinal adhesion (in the small intestine), with quantitative description

    Time frame: at the beginning of the second surgical procedure

  6. immediate complications in relation with operating procedure.

    Time frame: during the 2nd surgical procedure

  7. early complications (after 2ng operation) in relation with operating procedure.

    Time frame: during post-surgery hospitalization

  8. late complications in relation with operating procedure.

    Time frame: in the month following the 2nd intervention

  9. post-operative rehabilitation

    Time frame: during post-surgery hospitalization

  10. tumour evolution in patients

    Time frame: over a period of 3 years after the 2nd surgery

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study 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

Acronym: SEPRAC2T

Important dates

Study start
2008
Primary completion
2010
First posted
Dec 17, 2010
Registry last updated
Dec 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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