Hernia
Conditions
Keywords
Herniorrhaphy
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.
Interventions
None listed
Sponsors
Ethicon, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Assessment of post-operative complications/safety | At the time of surgery |
| Assessment of procedure time | At the time of surgery |
Countries
Australia, Belgium, Canada, China, France, Germany, Italy, Netherlands, South Africa, Spain, Sweden, United Kingdom, United States
Outcome results
None listed