A Two-Year Follow-up, Post Implantation, Multi-Center, International Hernia Mesh Registry
- Conditions
- hernia repair or herniorrhaphy10041297
- Registration Number
- NL-OMON36942
- Lead Sponsor
- Johnson & Johnson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
4.1. Inclusion Criteria
Patients must satisfy the following criteria before entering the registry:
1. Provide written informed consent;
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. Be scheduled to receive a surgically implanted mesh product for repair of a hernia defect;
5. Agree to provide long-term, outcomes data to Outcome Sciences;
6. Agree to provide contact information.
4.2. 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;
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 utilizing more than one mesh or device (except bilateral femoral, if operated on the same day). Two or more pieces of the same mesh product sewn together will be considered as one mesh, and is therefore allowed in this registry;
9. Patients requiring any other (concomitant) surgical procedure;
10. Patients suffering from an ongoing infection, sepsis, contaminated mesh or fistulas;
11. Patients who require inguinal hernia repair.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The co-primary effectiveness variables are to evaluate the outcomes of the<br /><br>hernia procedure defined as:<br /><br>• Recurrence of the hernia<br /><br>• Pain assessment scores provided by patients for the duration of the registry:<br /><br>o Acute Pain<br /><br>o Chronic Pain</p><br>
- Secondary Outcome Measures
Name Time Method