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

Centre Hospitalier Régional Universitaire Montpellier

Status and phase: Completed; Phase 3

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

Treatments: Procedure: Technique Tutomesh®; Procedure: Conventional technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01073072

2008-A00875-50

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Tutomesh

Experimental group

Description:

Technique of abdominal wall reconstruction strengthened by Tutomesh®

Treatment:

Procedure: Technique Tutomesh®

conventional repair

Active Comparator group

Description:

Conventional technique to repair incisional or abdominal wall hernias

Treatment:

Procedure: Conventional technique