Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5179 participants
OBSERVATIONAL
2007-09-01
2021-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Observation Group
Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Provide written informed consent prior to surgery;
2. Male or female patients that are \> 18 years of age;
3. Be literate and able to understand a language available in the Registry Patient Questionnaires;
4. Scheduled to receive a surgically implanted ETHICON synthetic mesh using any fixation method or a non-ETHICON synthetic mesh which must be fixated with SECURESTRAP® or SECURESTRAP® Open for repair of a hernia defect;
5. Agree to provide long-term, outcomes data to Quintiles Outcome;
6. Agree to provide contact information;
7. Two or more pieces of the same mesh product sewn together will be considered as one mesh, and is therefore allowed in this registry
Exclusion Criteria
1. Patients that are \<18 years of age;
2. Patients who have been entered into the registry previously;
3. Employees of the investigator or registry center with direct involvement in the proposed registry or other studies under the direction of that investigator or registry center and employees of ETHICON;
4. Patients suffering from and currently receiving medication for chronic pain (defined as suffering pain for greater than 3 months);
5. Patients known to be suffering from pre-existing chronic depression;
6. Patients currently known or suspected to abuse drugs or alcohol;
7. Patients suffering from a terminal illness (e.g. cancer);
8. Patients requiring multiple hernia repairs (including bilateral inguinal/femoral);
9. Patients requiring any other (concomitant) surgical procedure;
10. Patients suffering from an ongoing infection, sepsis, contaminated mesh or fistulas;
11. Patients who require hiatal, paraesophageal or diaphragmatic hernia repair;
12. Patients requiring two different types of meshes;
13. Patients requiring two or more meshes not sewn together
14. Patients scheduled to receive a surgically implanted biologic mesh product for repair of a hernia defect
18 Years
ALL
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Niels-Derrek Schmitz, M.D.
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Florida Hospital Celebration Health
Celebration, Florida, United States
Center for Hernia Repair
Sarasota, Florida, United States
Steward Norwood Hospital
Norwood, Massachusetts, United States
University of Missouri-Columbia
Columbia, Missouri, United States
SurgiCare of Missouri, P.C.
Jefferson City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Queens Long Island Medical Group
Hicksville, New York, United States
Laparoscopic Surgical Center of New York
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Owen Drive Surgical Clinic of Fayetteville
Fayetteville, North Carolina, United States
Pinehurst Surgical Center
Pinehurst, North Carolina, United States
South East Area Health Education Center (SEAHEC)
Wilmington, North Carolina, United States
Southwest Specialty Clinics
Oklahoma City, Oklahoma, United States
The Oregon Clinic
Portland, Oregon, United States
North Penn Surgical Associates
Lansdale, Pennsylvania, United States
Dallas Hernia Institute
Duncanville, Texas, United States
Kirby Surgical Center
Houston, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Queen Elizabeth Hospital
Woodville, South Australia, Australia
MercyCare Mount Lawley Hospital
Mount Lawley, Western Australia, Australia
The Wesley Hospital
Auchenflower, , Australia
Imelda Hospital
Bonheiden, , Belgium
University Hospital Ghent
Ghent, , Belgium
Centre for the Advancement of Minimally Invasive Surgery (CAMIS)
Edmonton, Alberta, Canada
Hamilton Health Sciences - General
Hamilton, Ontario, Canada
St. Joseph's Hospital
Hamilton, Ontario, Canada
Huadong Hospital- Affilated to Fudan University
Shanghai, , China
Hopital Prive D'Antony
Antony, , France
CH Avignon - Service de Chirurgie Digestive
Avignon, , France
CHU Hotel Dieu
Clermont-Ferrand, , France
Hospital Saint Philibert
Lomme, , France
Hopital Prive Mermoz
Lyon, , France
HIA Laveran
Marseille, , France
CHU de Nancy
Nancy, , France
Service de Chirurgie Generale et Cancerologie Digestiv
Nice, , France
Groupe Hospitalier Paris Saint-Joseph
Paris, , France
Centre Hospitalier Robert Debre
Reims, , France
Lukaskrankenhaus
Neuss, , Germany
Universita Cattolica Sacro Cuore
Rome, , Italy
Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
New Somerset Hospital
Cape Town, , South Africa
San Augustin De Aviles Hospital
Avilés, , Spain
University Hospital Virgen del Rocio
Seville, , Spain
Sodertalje Hospital
Södertälje, , Sweden
Hinchingbrooke Hospital
Huntingdon, Cambrideshire, United Kingdom
Royal United Hospital
Bath, Somerset, United Kingdom
University Hospitals of North Midlands
Stoke-on-Trent, Staffordshire, United Kingdom
Ayr Hospital
Ayr, , United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
Royal Bolton Hospital
Farnworth, , United Kingdom
St Mary's Hospital
London, , United Kingdom
North Tyneside General Hospital
North Shields, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Royal Alexandra Hospital
Paisley, , United Kingdom
Countries
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Other Identifiers
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200-06-007
Identifier Type: -
Identifier Source: org_study_id
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