International Hernia Mesh Registry (IHMR)

Ethicon

Status: Completed

Conditions: Hernia

Study type: Observational

Funder types: Industry

Identifiers

NCT00622583

200-06-007

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

5,179 participants in 1 patient group

Observation Group

Description:

Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.