Clinical trial NCT01073072: Study Comparing Tutomesh® Repair to Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Centre Hospitalier Régional Universitaire Montpellier
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits
timeFrame: 30 days
Secondary outcomes:
measure: recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report
timeFrame: 1 year
measure: the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics
timeFrame: 1 year
measure: the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations.
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: CH Aix en Provence
city: Amiens
country: France
facility: CHU Amiens
city: Antibes
country: France
facility: Ch Antibes-Juan les pins
city: Aubagne
country: France
facility: Clinique de la Casamance
city: Avignon
country: France
facility: CH Avignon
city: Beziers
country: France
facility: CHG Beziers
city: Bondy
country: France
facility: CHU Jean Verdier
city: Fréjus
country: France
facility: CHU Fréjus
city: Grenoble - La tronche
country: France
facility: CHU Grenoble
city: Marseille
country: France
facility: Hôpital Nord
city: Montpellier
country: France
facility: CH St Eloi
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Archet II
city: Nimes
country: France
facility: CH Nimes
city: Paris
country: France
facility: CHU Hôtel Dieu
city: Salon de Provence
country: France
facility: CH Salon de Provence
city: Strasbourg
country: France
facility: CH Hautepierre
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: CHU Trousseau
Study officials:
affiliation: University Hospital, Montpellier
name: David Nocca, Dr
role: PRINCIPAL_INVESTIGATOR
References: