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

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

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.

Study Overview

• Status: Completed
• Conditions: Potentially Contaminated Hernia Repair; Potentially Contaminated Abdominal Wall Reconstruction
• Intervention / Treatment: Procedure: Technique Tutomesh®; Procedure: Conventional technique

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13616
    • CH Aix en Provence
  • Amiens, France, 80054
    • CHU Amiens
  • Antibes, France
    • CH Antibes-Juan les Pins
  • Aubagne, France, 13400
    • Clinique de la Casamance
  • Avignon, France, 84900
    • Ch Avignon
  • Beziers, France, 34525
    • CHG Béziers
  • Bondy, France, 93143
    • CHU Jean VERDIER
  • Fréjus, France, 83600
    • CHU Fréjus
  • Grenoble - La tronche, France, 38700
    • CHU Grenoble
  • Marseille, France, 13915
    • Hopital Nord
  • Montpellier, France, 34000
    • CH St Eloi
  • Nantes, France
    • CHU Nantes
  • Nice, France, 06202
    • CHU Archet II
  • Nimes, France
    • CH Nîmes
  • Paris, France, 75004
    • Chu Hotel Dieu
  • Salon de Provence, France, 13658
    • Ch Salon de Provence
  • Strasbourg, France, 67200
    • CH Hautepierre
  • Toulouse, France, 31059
    • CHU Rangueil
  • Tours, France, 37000
    • CHU Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tutomesh; Technique of abdominal wall reconstruction strengthened by Tutomesh®	Procedure: Technique Tutomesh®; Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.
Active Comparator: conventional repair; Conventional technique to repair incisional or abdominal wall hernias	Procedure: Conventional technique; Conventional technique to repair potentially contaminated incisional or abdominal wall hernias

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Universitaire Montpellier
• Investigators: Principal Investigator: David Nocca, Dr, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 19, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): March 16, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: hernia repair; contamination; bovine pericardium bioprosthesis; abdominal wall reconstruction; Tutomesh; Tutopatch; Potentially Contaminated Hernia Repair; Potentially Contaminated Abdominal Wall Reconstruction
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 2008-A00875-50