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

NCT01073072 | Completed Phase 3

• 1 other identifier: 2008-A00875-50
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 19

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.

Conditions

Potentially Contaminated Hernia Repair; Potentially Contaminated Abdominal Wall Reconstruction

Keywords

bovine pericardium bioprosthesis; contamination; hernia repair; abdominal wall reconstruction; Tutomesh; Tutopatch; Potentially Contaminated Hernia Repair; Potentially Contaminated Abdominal Wall Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Tutomesh

EXPERIMENTAL

Technique of abdominal wall reconstruction strengthened by Tutomesh®

Procedure: Technique Tutomesh®

conventional repair

ACTIVE COMPARATOR

Conventional technique to repair incisional or abdominal wall hernias

Procedure: Conventional technique

Interventions

Conventional technique PROCEDURE

Conventional technique to repair potentially contaminated incisional or abdominal wall hernias

conventional repair

Technique Tutomesh® PROCEDURE

Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.

Tutomesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Universitaire Montpellier: lead

Study Sites (19)

CH Aix en Provence

Aix-en-Provence, 13616, France

Location

CHU Amiens

Amiens, 80054, France

Location

Ch Antibes-Juan les pins

Antibes, France

Location

Clinique de la Casamance

Aubagne, 13400, France

Location

CH Avignon

Avignon, 84900, France

Location

CHG Beziers

Béziers, 34525, France

Location

CHU Jean Verdier

Bondy, 93143, France

Location

CHU Fréjus

Fréjus, 83600, France

Location

CHU Grenoble

Grenoble - La Tronche, 38700, France

Location

Hôpital Nord

Marseille, 13915, France

Location

CH St Eloi

Montpellier, 34000, France

Location

CHU Nantes

Nantes, France

Location

CHU Archet II

Nice, 06202, France

Location

CH Nimes

Nîmes, France

Location

CHU Hôtel Dieu

Paris, 75004, France

Location

CH Salon de Provence

Salon-de-Provence, 13658, France

Location

CH Hautepierre

Strasbourg, 67200, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

CHU Trousseau

Tours, 37000, France

Location

Study Officials

• David Nocca, Dr

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. David NOCCA, CHRU Montpellier

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 23, 2010
• Study Start: January 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

FR (19)