International Hernia Mesh Registry (IHMR)
This study is currently recruiting participants.
Verified April 2013 by Ethicon, Inc.
Information provided by (Responsible Party):
First received: February 14, 2008
Last updated: April 25, 2013
Last verified: April 2013
To determine patient reported long-term outcomes, and post-implantation clinical characteristics related to the use of mesh products in 3,500 patients minimum.
||Time Perspective: Prospective
||A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
Primary Outcome Measures:
- Recurrence of the hernia [ Time Frame: 1 month, 6-months, 12 months, 2 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Intraoperative handling characteristics for each ETHICON lightweight mesh product and all biologic mesh products [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
- Assessment of post-operative complications/safety [ Time Frame: At the time of surgery ] [ Designated as safety issue: Yes ]
- Assessment of procedure time [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.
To help identify best practices leading to lower recurrence rates and decreases in chronic pain associated with the hernia repair procedure.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Primary care clinic and patients of the investigators at local clinics or hospitals.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622583
||Lynn McRoy, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 14, 2008
||April 25, 2013
||United States: Institutional Review Board
Canada: Ethics Review Committee
Italy: Ethics Committee
Germany: Ethics Commission
Netherlands: Independent Ethics Committee
Australia: Human Research Ethics Committee
Belgium: Institutional Review Board
Spain: Ethics Committee
United Kingdom: Research Ethics Committee
France: Institutional Ethical Committee
Sweden: Regional Ethical Review Board
Keywords provided by Ethicon, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Pathological Conditions, Anatomical