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

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

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

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

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. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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;

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 identifier (NCT number): NCT00622583

Contact: Christine Romanowski +1 908 218-3156

  Hide Study Locations
United States, California
UC Davis Medical Center Withdrawn
Sacramento, California, United States, 95817
United States, Florida
Florida Hospital Celebration Health Terminated
Celebration, Florida, United States, 34747
Center for Hernia Repair Terminated
Sarasota, Florida, United States, 34139
United States, Massachusetts
Steward Norwood Hospital Completed
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 Active, not recruiting
Saint 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
Owen Drive Surgical Clinic of Fayetteville Recruiting
Fayetteville, North Carolina, United States, 28304
Pinehurst Surgical Center Terminated
Pinehurst, North Carolina, United States, 28374
South East Area Health Education Center (SEAHEC) Active, not 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 Completed
Norfolk, Virginia, United States, 23507
Australia, South Australia
Queen Elizabeth Hospital Active, not recruiting
Woodville, South Australia, Australia, 5011
Australia, Western Australia
MercyCare Mount Lawley Hospital Recruiting
Mount Lawley, Western Australia, Australia, 6050
The Wesley Hospital Completed
Auchenflower, Australia, QLD 4066
Imelda Hospital Completed
Bonheiden, Belgium
University Hospital Ghent Recruiting
Gent, Belgium, 9000
Canada, Alberta
Centre for the Advancement of Minimally Invasive Surgery (CAMIS) Active, not recruiting
Edmonton, Alberta, Canada, T5H 1A8
Canada, British Columbia
Kelowna General Hospital Withdrawn
Kelowna, British Columbia, Canada
Vancouver Coastal Health Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Hamilton Health Sciences - General Recruiting
Hamilton, Ontario, Canada, L8L2X2
St. Joseph's Hospital Terminated
Hamilton, Ontario, Canada
China, Shanghai
Huadong Hospital- Affilated to Fudan University Active, not recruiting
Jing'an District, Shanghai, China
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 Completed
Nancy, France, 54038
Clinique St Georges Withdrawn
Nice, France, 06000
Service de Chirurgie Generale et Cancerologie Digestiv Completed
Nice, France, 06202
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
Lukaskrankenhaus Completed
Neuss, Germany, 41464
Ospedale di Adria Terminated
Adria, Italy, 945011
Universita Cattolica Sacro Cuore Recruiting
Rome, Italy
Jeroen Bosch Hospital Recruiting
Hertogenbosch, Netherlands, 5223 GZ
South Africa
New Somerset Hospital Recruiting
Cape Town, South Africa, 8051
San Augustin De Aviles Hospital Completed
Aviles, Spain, 33401
University Hospital Virgen del Rocio Completed
Sevilla, Spain, 41013
Sodertalje Hospital Recruiting
Sodertalje, Sweden, 152 86
United Kingdom
Hinchingbrooke Hospital Recruiting
Huntingdon, Cambrideshire, United Kingdom, PE29GNT
Royal United Hospital Recruiting
Bath, Somerset, United Kingdom, BA1 3NG
University Hospitals of North Midlands Recruiting
Stoke- on-Trent, Staffordshire, United Kingdom, ST46QG
Ayr Hospital Recruiting
Ayr, United Kingdom, KA6 6DX
Royal Bolton Hospital Recruiting
Lancashire, United Kingdom, BL4 0JR
St Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
North Tyneside General Hospital Completed
North Shields, United Kingdom
Northampton General Hospital Terminated
Northampton, United Kingdom
Royal Alexandra Hospital Completed
Paisley, United Kingdom, PA2 9PN
Sponsors and Collaborators
Ethicon, Inc.
Study Director: Niels D. Schmitz, M.D. Ethicon, Inc.

Responsible Party: Ethicon, Inc. 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.:

Additional relevant MeSH terms:
Pathological Conditions, Anatomical