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

Colorectal Cancer Clinical Trial

— SEPRAC2T  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262417
• Other study ID #: SEPRAC2T
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2010
• Last updated: December 16, 2010
• Start date: July 2008

Study information

• Verified date: May 2010
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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
• without resorbable barrier (seprafilm)
non use of resorbable membrane during the first surgery for the resection of hepatic metastases

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abdominal and peri-hepatic adhesion during the second operation		Time to liberate liver (t0: incision and t1: liberation)	No
Secondary	immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane		during the surgery	No
Secondary	early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane		during post-surgery hospitalization	No
Secondary	late complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane		between 1st and 2nd surgeries (2 operations should be scheduled at an interval of 1 to 6 months)	No
Secondary	abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description		at the beginning of the 2nd surgical procedure	No
Secondary	intestinal adhesion (in the small intestine), with quantitative description		at the beginning of the second surgical procedure	No
Secondary	immediate complications in relation with operating procedure.		during the 2nd surgical procedure	No
Secondary	early complications (after 2ng operation) in relation with operating procedure.		during post-surgery hospitalization	No
Secondary	late complications in relation with operating procedure.		in the month following the 2nd intervention	No
Secondary	post-operative rehabilitation		during post-surgery hospitalization	No
Secondary	tumour evolution in patients		over a period of 3 years after the 2nd surgery	No