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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tutomesh | Experimental | Technique of abdominal wall reconstruction strengthened by Tutomesh® |
|
| conventional repair | Active Comparator | Conventional technique to repair incisional or abdominal wall hernias |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional technique | Procedure | Conventional technique to repair potentially contaminated incisional or abdominal wall hernias |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Patient presenting with an incisional hernia or complicated hernia contraindicating the use of non absorbable mesh:
Patients signing informed consent form after reading and understanding the information letter _ Patients are more than 18 year old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Nocca, Dr | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Aix en Provence | Aix-en-Provence | 13616 | France | |||
| CHU Amiens |
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| Technique Tutomesh® | Procedure | Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment. |
|
| 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 |
| Amiens |
| 80054 |
| France |
| Ch Antibes-Juan les pins | Antibes | France |
| Clinique de la Casamance | Aubagne | 13400 | France |
| CH Avignon | Avignon | 84900 | France |
| CHG Beziers | Béziers | 34525 | France |
| CHU Jean Verdier | Bondy | 93143 | France |
| CHU Fréjus | Fréjus | 83600 | France |
| CHU Grenoble | Grenoble - La Tronche | 38700 | France |
| Hôpital Nord | Marseille | 13915 | France |
| CH St Eloi | Montpellier | 34000 | France |
| CHU Nantes | Nantes | France |
| CHU Archet II | Nice | 06202 | France |
| CH Nimes | Nîmes | France |
| CHU Hôtel Dieu | Paris | 75004 | France |
| CH Salon de Provence | Salon-de-Provence | 13658 | France |
| CH Hautepierre | Strasbourg | 67200 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| CHU Trousseau | Tours | 37000 | France |