Multicentric Prospective Randomized Study Comparing Technique of Tension-free Repair With Placement of a Bovine Pericardium Bioprosthesis (Tutopatch® and Tutomesh®) to Current Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction

Centre Hospitalier Régional Universitaire Montpellier19 sites in 1 country134 target enrollmentJanuary 2009

ConditionsPotentially Contaminated Hernia Repair Potentially Contaminated Abdominal Wall Reconstruction

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Potentially Contaminated Hernia Repair
Sponsor: Centre Hospitalier Régional Universitaire Montpellier
Enrollment: 134
Locations: 19
Primary Endpoint: risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction.

The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Régional Universitaire Montpellier

Responsible Party

Principal Investigator

David Nocca

Dr. David NOCCA, CHRU Montpellier

Centre Hospitalier Régional Universitaire Montpellier

Eligibility Criteria

Inclusion Criteria

•Patient presenting with an incisional hernia or complicated hernia contraindicating the use of non absorbable mesh:
•Infected incisional hernia: abdominal wall abscess, chronic fistula
•Incisional hernia with high septic potential: incisional hernia with strangulation of one or more intestinal loops, repair of incisional hernia during surgery requiring opening of the digestive tube (digestive resection, restoration of digestive continuity, gastro-intestinal perforation, peritonitis from digestive origin)
•Recurrent incisional hernia with problem of cutaneous healing
•Incisional hernia requiring important intestinal adhesiolysis
•Patients signing informed consent form after reading and understanding the information letter _ Patients are more than 18 year old

Exclusion Criteria

•Patient with major anesthetic risk (ASA 4)
•Patient suffering from immunodepression or under immunosuppressor treatment (corticoids...)
•Patients already enrolled in another study
•Patient suffering from severe disease not allowing a 1-year follow-up
•Patient refusing to be enrolled after consulting the information letter
•Patient presenting with a too large incisional hernia, superior to 140x200 mm
•Pregnancy

Outcomes

Primary Outcomes

risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits

Time Frame: 30 days

Secondary Outcomes

recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report(1 year)
the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics(1 year)
the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations.(1 year)
the impact on patients' quality of life: The evaluation of patient's quality of life will be done with the questionnaire quality of life SF12(1 year)