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

Primary Purpose

Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Conventional technique
Technique Tutomesh®
Sponsored by
Centre Hospitalier Régional Universitaire Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Potentially Contaminated Hernia Repair focused on measuring bovine pericardium bioprosthesis, contamination, hernia repair, abdominal wall reconstruction, Tutomesh, Tutopatch, Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CH Aix en Provence
  • CHU Amiens
  • Ch Antibes-Juan les pins
  • Clinique de la Casamance
  • CH Avignon
  • CHG Beziers
  • CHU Jean Verdier
  • CHU Fréjus
  • CHU Grenoble
  • Hôpital Nord
  • CH St Eloi
  • CHU Nantes
  • CHU Archet II
  • CH Nimes
  • CHU Hôtel Dieu
  • CH Salon de Provence
  • CH Hautepierre
  • CHU Rangueil
  • CHU Trousseau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tutomesh

conventional repair

Arm Description

Technique of abdominal wall reconstruction strengthened by Tutomesh®

Conventional technique to repair incisional or abdominal wall hernias

Outcomes

Primary Outcome Measures

risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits

Secondary Outcome Measures

recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report
the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics
the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations.
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

Full Information

First Posted
February 19, 2010
Last Updated
March 15, 2012
Sponsor
Centre Hospitalier Régional Universitaire Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01073072
Brief Title
Study Comparing Tutomesh® Repair to Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction
Acronym
Tutomesh
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Régional Universitaire Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tutomesh
Arm Type
Experimental
Arm Description
Technique of abdominal wall reconstruction strengthened by Tutomesh®
Arm Title
conventional repair
Arm Type
Active Comparator
Arm Description
Conventional technique to repair incisional or abdominal wall hernias
Intervention Type
Procedure
Intervention Name(s)
Conventional technique
Intervention Description
Conventional technique to repair potentially contaminated incisional or abdominal wall hernias
Intervention Type
Procedure
Intervention Name(s)
Technique Tutomesh®
Intervention Description
Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report
Time Frame
1 year
Title
the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics
Time Frame
1 year
Title
the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations.
Time Frame
1 year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Nocca, Dr
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Aix en Provence
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Ch Antibes-Juan les pins
City
Antibes
Country
France
Facility Name
Clinique de la Casamance
City
Aubagne
ZIP/Postal Code
13400
Country
France
Facility Name
CH Avignon
City
Avignon
ZIP/Postal Code
84900
Country
France
Facility Name
CHG Beziers
City
Beziers
ZIP/Postal Code
34525
Country
France
Facility Name
CHU Jean Verdier
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
CHU Fréjus
City
Fréjus
ZIP/Postal Code
83600
Country
France
Facility Name
CHU Grenoble
City
Grenoble - La tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hôpital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
CH St Eloi
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
CHU Archet II
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CH Nimes
City
Nimes
Country
France
Facility Name
CHU Hôtel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
CH Salon de Provence
City
Salon de Provence
ZIP/Postal Code
13658
Country
France
Facility Name
CH Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Trousseau
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

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

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