International Hernia Mesh Registry (IHMR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Ethicon, Inc.
Information provided by (Responsible Party):
Ethicon, Inc. Identifier:
First received: February 14, 2008
Last updated: November 9, 2015
Last verified: August 2015
To determine patient reported long-term outcomes, and post-implantation clinical characteristics related to the use of mesh products in 3,500 patients minimum.


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry

Resource links provided by NLM:

Further study details as provided by Ethicon, Inc.:

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: 3500
Study Start Date: September 2007
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Observation Group
Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.

Detailed Description:
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:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic and patients of the investigators at local clinics or hospitals.

Inclusion Criteria:

  • Provide written informed consent prior to surgery;
  • 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 synthetic mesh product for repair of a hernia defect;
  • Agree to provide long-term, outcomes data to Quintiles Outcome;
  • Agree to provide contact information;
  • Two or more pieces of the same manufacturer mesh product sewn together will be considered as one mesh, and is therefore allowed in this registry

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;
  • Patients requiring any other (concomitant) surgical procedure;
  • Patients suffering from an ongoing infection, sepsis, contaminated mesh or fistulas;
  • Patients who require hiatal, paraesophageal or diaphragmatic hernia repair;
  • Patients requiring two different types of meshes;
  • Patients scheduled to receive a surgically implanted biologic mesh product for repair of a hernia defect;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00622583

Contact: Christine Romanowski +1 908 218-3156

  Show 57 Study Locations
Sponsors and Collaborators
Ethicon, Inc.
Study Director: Niels D. Schmitz, M.D. Ethicon, Inc.
  More Information

Responsible Party: Ethicon, Inc. Identifier: NCT00622583     History of Changes
Other Study ID Numbers: 200-06-007 
Study First Received: February 14, 2008
Last Updated: November 9, 2015
Health Authority: 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
South Africa: Human Research Ethics Committee

Keywords provided by Ethicon, Inc.:

Additional relevant MeSH terms:
Pathological Conditions, Anatomical processed this record on May 26, 2016