Hernia Clinical Trial
— IHMROfficial title:
A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
Verified date | June 2023 |
Source | Ethicon, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 5179 |
Est. completion date | January 25, 2021 |
Est. primary completion date | April 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria Patients must satisfy the following criteria before entering the registry: 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 Patients who meet any of the following criteria will be excluded from participating in the registry: 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 |
Country | Name | City | State |
---|---|---|---|
Australia | The Wesley Hospital | Auchenflower | |
Australia | MercyCare Mount Lawley Hospital | Mount Lawley | Western Australia |
Australia | Queen Elizabeth Hospital | Woodville | South Australia |
Belgium | Imelda Hospital | Bonheiden | |
Belgium | University Hospital Ghent | Gent | |
Canada | 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 |
China | Huadong Hospital- Affilated to Fudan University | Shanghai | |
France | Hopital Prive D'Antony | Antony Cedex | |
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 | |
Germany | Lukaskrankenhaus | Neuss | |
Italy | Universita Cattolica Sacro Cuore | Rome | |
Netherlands | Jeroen Bosch Hospital | Hertogenbosch | |
South Africa | New Somerset Hospital | Cape Town | |
Spain | San Augustin De Aviles Hospital | Aviles | |
Spain | University Hospital Virgen del Rocio | Sevilla | |
Sweden | Sodertalje Hospital | Sodertalje | |
United Kingdom | Ayr Hospital | Ayr | |
United Kingdom | Royal United Hospital | Bath | Somerset |
United Kingdom | Dorset County Hospital | Dorchester | |
United Kingdom | Royal Bolton Hospital | Farnworth | |
United Kingdom | Hinchingbrooke Hospital | Huntingdon | Cambrideshire |
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 | University Hospitals of North Midlands | Stoke- on-Trent | Staffordshire |
United States | Florida Hospital Celebration Health | Celebration | Florida |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | University of Missouri-Columbia | Columbia | Missouri |
United States | Dallas Hernia Institute | Duncanville | Texas |
United States | Owen Drive Surgical Clinic of Fayetteville | Fayetteville | North Carolina |
United States | Queens Long Island Medical Group | Hicksville | New York |
United States | Kirby Surgical Center | Houston | Texas |
United States | SurgiCare of Missouri, P.C. | Jefferson City | Missouri |
United States | North Penn Surgical Associates | Lansdale | Pennsylvania |
United States | Laparoscopic Surgical Center of New York | New York | New York |
United States | Eastern Virginia Medical School | Norfolk | Virginia |
United States | Steward Norwood Hospital | Norwood | Massachusetts |
United States | Southwest Specialty Clinics | Oklahoma City | Oklahoma |
United States | Pinehurst Surgical Center | Pinehurst | North Carolina |
United States | The Oregon Clinic | Portland | Oregon |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Center for Hernia Repair | Sarasota | Florida |
United States | South East Area Health Education Center (SEAHEC) | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Ethicon, Inc. |
United States, Australia, Belgium, Canada, China, France, Germany, Italy, Netherlands, South Africa, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of the hernia | 1 month, 6-months, 12 months, 2 years | ||
Primary | 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 | Assessment of post-operative complications/safety | At the time of surgery | ||
Secondary | Assessment of procedure time | At the time of surgery |
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