Completed

NCT Number: NCT01073072

Study Comparing Tutomesh® Repair to 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Potentially Contaminated Hernia Repair Potentially Contaminated Abdominal Wall Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CH Aix en Provence, Aix-en-Provence, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional technique

Procedure

Conventional technique to repair potentially contaminated incisional or abdominal wall hernias

Technique Tutomesh®

Procedure

Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Universitaire Montpellier

Other

Registry information

Official study 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

Acronym: Tutomesh

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Feb 23, 2010
Registry last updated: Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.