International Hernia Mesh Registry (IHMR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ethicon, Inc.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00622583
First received: February 14, 2008
Last updated: July 28, 2014
Last verified: July 2014
  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 2019
Estimated Primary Completion Date: December 2017 (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

  Hide Study Locations
Locations
United States, California
UC Davis Medical Center Withdrawn
Sacramento, California, United States, 95817
United States, Florida
Florida Hospital Celebration Health Recruiting
Celebration, Florida, United States, 34747
Center for Hernia Repair Terminated
Sarasota, Florida, United States, 34139
United States, Massachusetts
Eastern Massachusetts Surgery Center Recruiting
Norwood, Massachusetts, United States, 02062
United States, Missouri
University of Missouri-Columbia Terminated
Columbia, Missouri, United States, 65212
SurgiCare of Missouri, P.C. Recruiting
Jefferson City, Missouri, United States, 65101
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Queens Long Island Medical Group Terminated
Hicksville, New York, United States, 11801
Laparoscopic Surgical Center of New York Terminated
New York, New York, United States, 10028
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232
Pinehurst Surgical Center Active, not recruiting
Pinehurst, North Carolina, United States, 28374
South East Area Health Education Center (SEAHEC) Recruiting
Wilmington, North Carolina, United States, 28403
United States, Oklahoma
Southwest Specialty Clinics Terminated
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
The Oregon Clinic Recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
North Penn Surgical Associates Completed
Lansdale, Pennsylvania, United States, 19446
United States, Texas
Dallas Hernia Institute Terminated
Duncanville, Texas, United States, 75116
Kirby Surgical Center Terminated
Houston, Texas, United States, 77098
United States, Virginia
Eastern Virginia Medical School Active, not recruiting
Norfolk, Virginia, United States, 23507
Australia, South Australia
Queen Elizabeth Hospital Recruiting
Woodville, South Australia, Australia, 5011
Australia, Western Australia
MercyCare Mount Lawley Hospital Recruiting
Mount Lawley, Western Australia, Australia, 6050
Australia
The Wesley Hospital Completed
Auchenflower, Australia, QLD 4066
Belgium
Imelda Hospital Recruiting
Bonheiden, Belgium
University Hospital Ghent Recruiting
Gent, Belgium, 9000
Canada, Alberta
Centre for the Advancement of Minimally Invasive Surgery (CAMIS) Recruiting
Edmonton, Alberta, Canada, T5H 1A8
Canada, British Columbia
Kelowna General Hospital Recruiting
Kelowna, British Columbia, Canada
Canada, Ontario
St. Joseph's Hospital Terminated
Hamilton, Ontario, Canada
Hamilton Health Sciences - General Recruiting
Hamilton, Ontario, Canada, L8L2X2
France
CH Antibes - Service de Chirurgie Withdrawn
Antibes, France, 06606
Hopital Prive D'Antony Completed
Antony Cedex, France
CH Avignon - Service de Chirurgie Digestive Terminated
Avignon, France, 84902
CHU Hotel Dieu Completed
Clermont-Ferrand, France
Hospital Saint Philibert Terminated
Lomme, France, 59462
Hopital Prive Mermoz Completed
Lyon, France, 69008
HIA Laveran Completed
Marseille, France, 13384
CHU de Nancy Recruiting
Nancy, France, 54038
Service de Chirurgie Generale et Cancerologie Digestiv Recruiting
Nice, France, 06202
Clinique St Georges Withdrawn
Nice, France, 06000
Groupe Hospitalier Paris Saint-Joseph Terminated
Paris, France, 75014
Centre Hospitalier Robert Debre Completed
Reims, France, 51092
Clinque de l' Orangerie / Cabinet de Chirurgie Withdrawn
Strasbourg, France, 67000
Germany
Lukaskrankenhaus Recruiting
Neuss, Germany, 41464
Italy
Ospedale di Adria Recruiting
Adria, Italy, 945011
Universita Cattolica Sacro Cuore Recruiting
Rome, Italy
Netherlands
Jeroen Bosch Hospital Recruiting
Hertogenbosch, Netherlands, 5223 GZ
South Africa
New Somerset Hospital Recruiting
Cape Town, South Africa, 8051
Spain
San Augustin De Aviles Hospital Completed
Aviles, Spain, 33401
University Hospital Virgen del Rocio Completed
Sevilla, Spain, 41013
Sweden
Sodertalje Hospital Recruiting
Sodertalje, Sweden, 152 86
United Kingdom
Ayr Hospital Recruiting
Ayr, United Kingdom, KA6 6DX
Royal Bolton Hospital Recruiting
Lancashire, United Kingdom, BL4 0JR
North Tyneside General Hospital Completed
North Shields, United Kingdom
Northampton General Hospital Recruiting
Northampton, United Kingdom
Royal Alexandra Hospital Active, not recruiting
Paisley, United Kingdom, PA2 9PN
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Jeffrey Hammond, 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: July 28, 2014
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 September 16, 2014