Study Comparing Tutomesh® Repair to Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction

Phase 3

Completed

• Conditions: Potentially Contaminated Hernia Repair; Potentially Contaminated Abdominal Wall Reconstruction

• Registration Number: NCT01073072
• Lead Sponsor: Centre Hospitalier Régional Universitaire Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Primary Completion: 2010-10
• Study Completion: 2011-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

CH Aix en Provence; 🇫🇷 Aix en Provence, France

CHU Amiens; 🇫🇷 Amiens, France

Ch Antibes-Juan les pins; 🇫🇷 Antibes, France

Clinique de la Casamance; 🇫🇷 Aubagne, France

CH Avignon; 🇫🇷 Avignon, France

CHG Beziers; 🇫🇷 Beziers, France

CHU Jean Verdier; 🇫🇷 Bondy, France

CHU Fréjus; 🇫🇷 Fréjus, France

CHU Grenoble; 🇫🇷 Grenoble - La tronche, France

Hôpital Nord; 🇫🇷 Marseille, France

Scroll for more (9 remaining)