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International Hernia Mesh Registry (IHMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00622583
Recruitment Status : Recruiting
First Posted : February 25, 2008
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Brief Summary:
This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally

Condition or disease
Hernia

Detailed Description:
Patients will be followed for 2-years post-implantation, in a post-market setting to help identify best practices leading to lower recurrence rates and decreases in chronic pain, associated with the hernia repair procedure.

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Study Type : Observational
Estimated Enrollment : 4800 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 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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



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. Assessment of post-operative complications/safety [ Time Frame: At the time of surgery ]
  2. Assessment of procedure time [ Time Frame: At the time of surgery ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic and patients of the investigators at local clinics or hospitals.
Criteria

Inclusion Criteria

Patients must satisfy the following criteria before entering the registry:

  1. Provide written informed consent prior to surgery;
  2. Male or female patients that are > 18 years of age;
  3. Be literate and able to understand a language available in the Registry Patient Questionnaires;
  4. Scheduled to receive a surgically implanted ETHICON synthetic mesh using any fixation method or a non-ETHICON synthetic mesh which must be fixated with SECURESTRAP® or SECURESTRAP® Open for repair of a hernia defect;
  5. Agree to provide long-term, outcomes data to Quintiles Outcome;
  6. Agree to provide contact information;
  7. Two or more pieces of the same mesh product sewn together will be considered as one mesh, and is therefore allowed in this registry

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participating in the registry:

  1. Patients that are <18 years of age;
  2. Patients who have been entered into the registry previously;
  3. 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;
  4. Patients suffering from and currently receiving medication for chronic pain (defined as suffering pain for greater than 3 months);
  5. Patients known to be suffering from pre-existing chronic depression;
  6. Patients currently known or suspected to abuse drugs or alcohol;
  7. Patients suffering from a terminal illness (e.g. cancer);
  8. Patients requiring multiple hernia repairs (including bilateral inguinal/femoral);
  9. Patients requiring any other (concomitant) surgical procedure;
  10. Patients suffering from an ongoing infection, sepsis, contaminated mesh or fistulas;
  11. Patients who require hiatal, paraesophageal or diaphragmatic hernia repair;
  12. Patients requiring two different types of meshes;
  13. Patients requiring two or more meshes not sewn together
  14. Patients scheduled to receive a surgically implanted biologic mesh product for repair of a hernia defect

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

Locations
Show Show 60 study locations
Sponsors and Collaborators
Ethicon, Inc.
Investigators
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Study Director: Niels-Derrek Schmitz, M.D. Ethicon, Inc.

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Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00622583    
Other Study ID Numbers: 200-06-007
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Keywords provided by Ethicon, Inc.:
Herniorrhaphy
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical