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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
Conventional technique to repair potentially contaminated incisional or abdominal wall hernias
Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.
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
Béziers, France
CHU Jean Verdier
Bondy, France
CHU Fréjus
Fréjus, France
CHU Grenoble
Grenoble - La Tronche, France
Hôpital Nord
Marseille, France
...and 9 more locations
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
recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report
Time frame: 1 year
the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics
Time frame: 1 year
the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations.
Time frame: 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
Time frame: 1 year
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