International Hernia Mesh Registry (IHMR)

A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry

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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 5179

Contacts and Locations

Study Locations

• Australia
  • Auchenflower, Australia, QLD 4066
    • The Wesley Hospital
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • Queen Elizabeth Hospital
  • Western Australia
    • Mount Lawley, Western Australia, Australia, 6050
      • MercyCare Mount Lawley Hospital
• Belgium
  • Bonheiden, Belgium
    • Imelda Hospital
  • Gent, Belgium, 9000
    • University Hospital Ghent
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 1A8
      • Centre for the Advancement of Minimally Invasive Surgery (CAMIS)
  • Ontario
    • Hamilton, Ontario, Canada
      • St. Joseph's Hospital
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton Health Sciences - General
• China
  • Shanghai, China
    • Huadong Hospital- Affilated to Fudan University
• France
  • Antony Cedex, France
    • Hopital Prive d'Antony
  • Avignon, France, 84902
    • CH Avignon - Service de Chirurgie Digestive
  • Clermont-Ferrand, France
    • Chu Hotel Dieu
  • Lomme, France, 59462
    • Hospital Saint Philibert
  • Lyon, France, 69008
    • Hopital Prive Mermoz
  • Marseille, France, 13384
    • Hia Laveran
  • Nancy, France, 54038
    • Chu de Nancy
  • Nice, France, 06202
    • Service de Chirurgie Generale et Cancerologie Digestiv
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph
  • Reims, France, 51092
    • Centre Hospitalier Robert Debre
• Germany
  • Neuss, Germany, 41464
    • Lukaskrankenhaus
• Italy
  • Rome, Italy
    • Universita Cattolica Sacro Cuore
• Netherlands
  • Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Hospital
• South Africa
  • Cape Town, South Africa, 8051
    • New Somerset Hospital
• Spain
  • Aviles, Spain, 33401
    • San Augustin De Aviles Hospital
  • Sevilla, Spain, 41013
    • University Hospital Virgen del Rocio
• Sweden
  • Sodertalje, Sweden, 152 86
    • Södertälje Hospital
• United Kingdom
  • Ayr, United Kingdom, KA6 6DX
    • Ayr Hospital
  • Dorchester, United Kingdom, DT12JY
    • Dorset County Hospital
  • Farnworth, United Kingdom, BL4 0JR
    • Royal Bolton Hospital
  • London, United Kingdom, W2 1NY
    • St Mary's Hospital
  • North Shields, United Kingdom
    • North Tyneside General Hospital
  • Northampton, United Kingdom
    • Northampton General Hospital
  • Paisley, United Kingdom, PA2 9PN
    • Royal Alexandra Hospital
  • Cambrideshire
    • Huntingdon, Cambrideshire, United Kingdom, PE29GNT
      • Hinchingbrooke Hospital
  • Somerset
    • Bath, Somerset, United Kingdom, BA1 3NG
      • Royal United Hospital
  • Staffordshire
    • Stoke- on-Trent, Staffordshire, United Kingdom, ST46QG
      • University Hospitals of North Midlands
• United States
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital Celebration Health
    • Sarasota, Florida, United States, 34139
      • Center for Hernia Repair
  • Massachusetts
    • Norwood, Massachusetts, United States, 02062
      • Steward Norwood Hospital
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia
    • Jefferson City, Missouri, United States, 65101
      • SurgiCare of Missouri, P.C.
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • Hicksville, New York, United States, 11801
      • Queens Long Island Medical Group
    • New York, New York, United States, 10028
      • Laparoscopic Surgical Center of New York
  • North Carolina
    • Charlotte, North Carolina, United States, 28232
      • Carolinas Medical Center
    • Fayetteville, North Carolina, United States, 28304
      • Owen Drive Surgical Clinic of Fayetteville
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Surgical Center
    • Wilmington, North Carolina, United States, 28403
      • South East Area Health Education Center (SEAHEC)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Southwest Specialty Clinics
  • Oregon
    • Portland, Oregon, United States, 97225
      • The Oregon Clinic
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • North Penn Surgical Associates
  • Texas
    • Duncanville, Texas, United States, 75116
      • Dallas Hernia Institute
    • Houston, Texas, United States, 77098
      • Kirby Surgical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic and patients of the investigators at local clinics or hospitals.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence of the hernia	1 month, 6-months, 12 months, 2 years
Pain assessment scores by patients for the duration of the registry (Acute pain and Chronic pain)	1 month, 6-months, 12 months, 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of post-operative complications/safety	At the time of surgery
Assessment of procedure time	At the time of surgery

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Study Director: Niels-Derrek Schmitz, M.D., Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2007
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): January 25, 2021

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimated): February 25, 2008

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Herniorrhaphy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 200-06-007