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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Nocca, Centre Hospitalier Régional Universitaire Montpellier
ClinicalTrials.gov Identifier:
NCT01073072
First received: February 19, 2010
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Potentially Contaminated Hernia Repair
Potentially Contaminated Abdominal Wall Reconstruction
 Procedure: Conventional technique
Procedure: Technique Tutomesh®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Régional Universitaire Montpellier:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073072

Locations
France
CH Aix en Provence
Aix en Provence, France, 13616
CHU Amiens
Amiens, France, 80054
Ch Antibes-Juan les pins
Antibes, France
Clinique de la Casamance
Aubagne, France, 13400
CH Avignon
Avignon, France, 84900
CHG Beziers
Beziers, France, 34525
CHU Jean Verdier
Bondy, France, 93143
CHU Fréjus
Fréjus, France, 83600
CHU Grenoble
Grenoble - La tronche, France, 38700
Hôpital Nord
Marseille, France, 13915
CH St Eloi
Montpellier, France, 34000
CHU Nantes
Nantes, France
CHU Archet II
Nice, France, 06202
CH Nimes
Nimes, France
CHU Hôtel Dieu
Paris, France, 75004
CH Salon de Provence
Salon de Provence, France, 13658
CH Hautepierre
Strasbourg, France, 67200
CHU Rangueil
Toulouse, France, 31059
CHU Trousseau
Tours, France, 37000
Sponsors and Collaborators
Centre Hospitalier Régional Universitaire Montpellier
Investigators
Principal Investigator: David Nocca, Dr University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: David Nocca, Dr. David NOCCA, CHRU Montpellier, Centre Hospitalier Régional Universitaire Montpellier
ClinicalTrials.gov Identifier: NCT01073072     History of Changes
Other Study ID Numbers: 2008-A00875-50
Study First Received: February 19, 2010
Last Updated: March 15, 2012
Health Authority: France: National Consultative Ethics Committee For patients' protection

Keywords provided by Centre Hospitalier Régional Universitaire Montpellier:
bovine pericardium bioprosthesis
contamination
hernia repair
abdominal wall reconstruction
 Tutomesh
Tutopatch
Potentially Contaminated Hernia Repair
Potentially Contaminated Abdominal Wall Reconstruction

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013