International Hernia Mesh Registry
- Conditions
- Hernia
- Registration Number
- NCT00622583
- Lead Sponsor
- Ethicon, Inc.
- Brief Summary
This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally
- Detailed Description
Patients will be followed for 2-years post-implantation, in a post-market setting to help identify best practices leading to lower recurrence rates and decreases in chronic pain, associated with the hernia repair procedure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5179
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence of the hernia 1 month, 6-months, 12 months, 2 years Pain assessment scores by patients for the duration of the registry (Acute pain and Chronic pain) 1 month, 6-months, 12 months, 2 years
- Secondary Outcome Measures
Name Time Method Assessment of procedure time At the time of surgery Assessment of post-operative complications/safety At the time of surgery
Trial Locations
- Locations (54)
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Huadong Hospital- Affilated to Fudan University
🇨🇳Shanghai, China
CH Avignon - Service de Chirurgie Digestive
🇫🇷Avignon, France
Hospital Saint Philibert
🇫🇷Lomme, France
The Wesley Hospital
🇦🇺Auchenflower, Australia
Center for Hernia Repair
🇺🇸Sarasota, Florida, United States
North Penn Surgical Associates
🇺🇸Lansdale, Pennsylvania, United States
Steward Norwood Hospital
🇺🇸Norwood, Massachusetts, United States
St. Joseph's Hospital
🇨🇦Hamilton, Ontario, Canada
Owen Drive Surgical Clinic of Fayetteville
🇺🇸Fayetteville, North Carolina, United States
Dallas Hernia Institute
🇺🇸Duncanville, Texas, United States
Florida Hospital Celebration Health
🇺🇸Celebration, Florida, United States
Queens Long Island Medical Group
🇺🇸Hicksville, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
University Hospital Ghent
🇧🇪Gent, Belgium
CHU Hotel Dieu
🇫🇷Clermont-Ferrand, France
St Mary's Hospital
🇬🇧London, United Kingdom
Laparoscopic Surgical Center of New York
🇺🇸New York, New York, United States
Royal Bolton Hospital
🇬🇧Farnworth, United Kingdom
University Hospitals of North Midlands
🇬🇧Stoke- on-Trent, Staffordshire, United Kingdom
Hamilton Health Sciences - General
🇨🇦Hamilton, Ontario, Canada
Imelda Hospital
🇧🇪Bonheiden, Belgium
Universita Cattolica Sacro Cuore
🇮🇹Rome, Italy
Ayr Hospital
🇬🇧Ayr, United Kingdom
New Somerset Hospital
🇿🇦Cape Town, South Africa
Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
CHU de Nancy
🇫🇷Nancy, France
Centre Hospitalier Robert Debre
🇫🇷Reims, France
North Tyneside General Hospital
🇬🇧North Shields, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, United Kingdom
San Augustin De Aviles Hospital
🇪🇸Aviles, Spain
Service de Chirurgie Generale et Cancerologie Digestiv
🇫🇷Nice, France
Hinchingbrooke Hospital
🇬🇧Huntingdon, Cambrideshire, United Kingdom
University of Missouri-Columbia
🇺🇸Columbia, Missouri, United States
Pinehurst Surgical Center
🇺🇸Pinehurst, North Carolina, United States
Jeroen Bosch Hospital
🇳🇱Hertogenbosch, Netherlands
SurgiCare of Missouri, P.C.
🇺🇸Jefferson City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
South East Area Health Education Center (SEAHEC)
🇺🇸Wilmington, North Carolina, United States
Centre for the Advancement of Minimally Invasive Surgery (CAMIS)
🇨🇦Edmonton, Alberta, Canada
Hopital Prive Mermoz
🇫🇷Lyon, France
Lukaskrankenhaus
🇩🇪Neuss, Germany
University Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Sodertalje Hospital
🇸🇪Sodertalje, Sweden
Northampton General Hospital
🇬🇧Northampton, United Kingdom
MercyCare Mount Lawley Hospital
🇦🇺Mount Lawley, Western Australia, Australia
Royal United Hospital
🇬🇧Bath, Somerset, United Kingdom
Southwest Specialty Clinics
🇺🇸Oklahoma City, Oklahoma, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Kirby Surgical Center
🇺🇸Houston, Texas, United States
Hopital Prive D'Antony
🇫🇷Antony Cedex, France
HIA Laveran
🇫🇷Marseille, France
Groupe Hospitalier Paris Saint-Joseph
🇫🇷Paris, France