International Hernia Mesh Registry

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2023
• Main ID: NCT00622583
• Date of registration: 14/02/2008
• Prospective Registration: No
• Primary sponsor: Ethicon, Inc.
• Public title: International Hernia Mesh Registry IHMR
• Scientific title: A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
• Date of first enrolment: September 1, 2007
• Target sample size: 5179
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00622583
• Study type: Observational

Countries of recruitment

Australia, Belgium, Canada, China, France, Germany, Italy, Netherlands, South Africa, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Niels-Derrek Schmitz, M.D.
• Affiliation: Ethicon, Inc.

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hernia

Primary Outcome(s)

Recurrence of the hernia [Time Frame: 1 month, 6-months, 12 months, 2 years]

Pain assessment scores by patients for the duration of the registry (Acute pain and Chronic pain) [Time Frame: 1 month, 6-months, 12 months, 2 years]

Secondary Outcome(s)

Assessment of post-operative complications/safety [Time Frame: At the time of surgery]

Assessment of procedure time [Time Frame: At the time of surgery]

Secondary ID(s)

200-06-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors