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International Hernia Mesh Registry (IHMR)

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ClinicalTrials.gov Identifier: NCT00622583
Recruitment Status : Recruiting
First Posted : February 25, 2008
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Hernia

Detailed Description:
To help identify best practices leading to lower recurrence rates and decreases in chronic pain associated with the hernia repair procedure.

Study Design

Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
Actual Study Start Date : September 1, 2007
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Observation Group
Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.


Outcome Measures

Primary Outcome Measures :
  1. Recurrence of the hernia [ Time Frame: 1 month, 6-months, 12 months, 2 years ]
  2. 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 ]

Secondary Outcome Measures :
  1. Intraoperative handling characteristics for each ETHICON lightweight mesh product and all biologic mesh products [ Time Frame: At the time of surgery ]
  2. Assessment of post-operative complications/safety [ Time Frame: At the time of surgery ]
  3. Assessment of procedure time [ Time Frame: At the time of surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622583


Contacts
Contact: Christine Romanowski +1 908 218-3156 cromanow@its.jnj.com

  Show 60 Study Locations
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Niels D. Schmitz, M.D. Ethicon, Inc.
More Information

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00622583     History of Changes
Other Study ID Numbers: 200-06-007
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

Keywords provided by Ethicon, Inc.:
Herniorrhaphy

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical