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A Five-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry

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Trial Conditions
  • Hernia
What is the purpose of this trial?

To determine patient reported long-term outcomes, and post-implantation clinical characteristics related to the use of mesh products in 3,500 patients minimum.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Provide written informed consent;

- Male or female patients that are greater than or equal to 18 years of age

- Be literate and able to understand a language available in the Registry Patient
Questionnaires;

- Be scheduled to receive a surgically implanted mesh product (synthetic or biologic)
for repair of a hernia defect;

- Agree to provide long-term, outcomes data to Outcome Sciences, Inc;

- Agree to provide contact information.

Exclusion Criteria:

- Patients that are <18 years of age;

- Patients who have been entered into the registry previously;

- 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;

- Patients suffering from and currently receiving medication for chronic pain;

- Patients known to be suffering from pre-existing chronic depression;

- Patients currently known or suspected to abuse drugs or alcohol;

- Patients suffering from a terminal illness (e.g. cancer);

- Patients requiring multiple hernia repairs utilizing more than one mesh or device,
except bilateral inguinal or 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.

- Patients scheduled to receive both a synthetic and biologic mesh during the same
procedure

- Patients requiring any other (concomitant) surgical procedure;

- Patients suffering from an ongoing infection.

Gender: Both
Steward Physician(s)
  • Lynn McRoy, M.D.
Physician Researcher

Investigator Name:

  • Lynn McRoy, M.D.

Other Information

Sponsor: Ethicon, Inc.
Phase: N/A
Trial ID: NCT00622583
Volunteers:  Accepting Healthy Volunteers

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