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International Hernia Mesh Registry (IHMR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Ethicon, Inc.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00622583
First received: February 14, 2008
Last updated: August 10, 2016
Last verified: April 2016
History of Changes

February 14, 2008
August 10, 2016
September 2007
December 2017   (final data collection date for primary outcome measure)
  • 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 ]
  • Recurrence of the hernia [ Time Frame: 1 month, 6-months, 12 months, 2 years, 3 years, 4 years, 5 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, 3 years, 4 years, 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00622583 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Intraoperative handling characteristics for each ETHICON mesh product [ 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 ]
Not Provided
Not Provided
 
International Hernia Mesh Registry
A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
To determine patient reported long-term outcomes, and post-implantation clinical characteristics related to the use of mesh products in 3,500 patients minimum.
To help identify best practices leading to lower recurrence rates and decreases in chronic pain associated with the hernia repair procedure.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Primary care clinic and patients of the investigators at local clinics or hospitals.
Hernia
Not Provided
Observation Group
Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3500
December 2019
December 2017   (final data collection date for primary outcome measure)

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;
Both
18 Years and older   (Adult, Senior)
Yes
Contact: Christine Romanowski +1 908 218-3156 cromanow@its.jnj.com
United States,   Australia,   Belgium,   Canada,   China,   France,   Germany,   Italy,   Netherlands,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00622583
200-06-007
No
Not Provided
Not Provided
Ethicon, Inc.
Ethicon, Inc.
Not Provided
Study Director: Niels D. Schmitz, M.D. Ethicon, Inc.
Ethicon, Inc.
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP