Potentially Contaminated Abdominal Wall Reconstruction Clinical Trial
— TutomeshOfficial 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
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.
| Status | Completed |
| Enrollment | 134 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | CH St Eloi | Montpellier | |
| France | CHU Nantes | Nantes | |
| France | CHU Archet II | Nice | |
| France | CH Nimes | Nimes | |
| France | CHU Hôtel Dieu | Paris | |
| France | CH Salon de Provence | Salon de Provence | |
| France | CH Hautepierre | Strasbourg | |
| France | CHU Rangueil | Toulouse | |
| France | CHU Trousseau | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Régional Universitaire Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report | 1 year | Yes | |
| Secondary | the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics | 1 year | No | |
| Secondary | the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations. | 1 year | No | |
| Secondary | 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 | No |