International Hernia Mesh Registry (IHMR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Ethicon, Inc.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00622583
First received: February 14, 2008
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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


Condition
Hernia

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 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

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.

Criteria

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.
  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 ClinicalTrials.gov identifier: NCT00622583

Contacts
Contact: John Lombard 908 218-2877 jlombard8@its.jnj.com

  Show 52 Study Locations
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Lynn McRoy, M.D. Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00622583     History of Changes
Other Study ID Numbers: 200-06-007
Study First Received: February 14, 2008
Last Updated: April 25, 2013
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

Keywords provided by Ethicon, Inc.:
Herniorrhaphy

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014