HerniaIHMRNCT00622583
International Hernia Mesh Registry
An observational study of Hernia, run by Ethicon, Inc. at 54 sites in 13 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia
- How many people
- 5,179 participants
- Where
- 54 sitesin 13 countries
- Study dates
- 1 Sep 2007to 25 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic and patients of the investigators at local clinics or hospitals.
Who may be able to join
- Patients must satisfy the following criteria before entering the registry:
- Provide written informed consent prior to surgery;
- Male or female patients that are > 18 years of age;
- Be literate and able to understand a language available in the Registry Patient Questionnaires;
- 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;
- Agree to provide long-term, outcomes data to Quintiles Outcome;
- Agree to provide contact information;
- Two or more pieces of the same mesh product sewn together will be considered as one mesh, and is therefore allowed in this registry
Who cannot join
- Patients who meet any of the following criteria will be excluded from participating in the registry:
- 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 (defined as suffering pain for greater than 3 months);
- Patients known to be suffering from pre-existing chronic depression;
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- Patients currently known or suspected to abuse drugs or alcohol;
- Patients suffering from a terminal illness (e.g. cancer);
- Patients requiring multiple hernia repairs (including bilateral inguinal/femoral);
- 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 requiring two or more meshes not sewn together
- Patients scheduled to receive a surgically implanted biologic mesh product for repair of a hernia defect
Trial locations and contacts
54 sites in 13 countries.
54 sites in 13 countries
United States18 sites
Florida Hospital Celebration Health
Celebration, Florida, 34747
Carolinas Medical Center
Charlotte, North Carolina, 28232
University of Missouri-Columbia
Columbia, Missouri, 65212
Dallas Hernia Institute
Duncanville, Texas, 75116
Owen Drive Surgical Clinic of Fayetteville
Fayetteville, North Carolina, 28304
Queens Long Island Medical Group
Hicksville, New York, 11801
Kirby Surgical Center
Houston, Texas, 77098
SurgiCare of Missouri, P.C.
Jefferson City, Missouri, 65101
North Penn Surgical Associates
Lansdale, Pennsylvania, 19446
Laparoscopic Surgical Center of New York
New York, New York, 10028
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Steward Norwood Hospital
Norwood, Massachusetts, 02062
Southwest Specialty Clinics
Oklahoma City, Oklahoma, 73109
Pinehurst Surgical Center
Pinehurst, North Carolina, 28374
The Oregon Clinic
Portland, Oregon, 97225
Center for Hernia Repair
Sarasota, Florida, 34139
Washington University School of Medicine
St Louis, Missouri, 63110
South East Area Health Education Center (SEAHEC)
Wilmington, North Carolina, 28403
France10 sites
Hopital Prive D'Antony
Antony
CH Avignon - Service de Chirurgie Digestive
Avignon, 84902
CHU Hotel Dieu
Clermont-Ferrand
Hospital Saint Philibert
Lomme, 59462
Hopital Prive Mermoz
Lyon, 69008
HIA Laveran
Marseille, 13384
CHU de Nancy
Nancy, 54038
Service de Chirurgie Generale et Cancerologie Digestiv
Nice, 06202
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Centre Hospitalier Robert Debre
Reims, 51092
United Kingdom10 sites
Ayr Hospital
Ayr, KA6 6DX
Royal United Hospital
Bath, Somerset, BA1 3NG
Dorset County Hospital
Dorchester, DT12JY
Royal Bolton Hospital
Farnworth, BL4 0JR
Hinchingbrooke Hospital
Huntingdon, Cambrideshire, PE29GNT
St Mary's Hospital
London, W2 1NY
North Tyneside General Hospital
North Shields
Northampton General Hospital
Northampton
Royal Alexandra Hospital
Paisley, PA2 9PN
University Hospitals of North Midlands
Stoke-on-Trent, Staffordshire, ST46QG
Australia3 sites
The Wesley Hospital
Auchenflower, QLD 4066
MercyCare Mount Lawley Hospital
Mount Lawley, Western Australia, 6050
Queen Elizabeth Hospital
Woodville, South Australia, 5011
Canada3 sites
Centre for the Advancement of Minimally Invasive Surgery (CAMIS)
Edmonton, Alberta, T5H 1A8
Hamilton Health Sciences - General
Hamilton, Ontario, L8L2X2
St. Joseph's Hospital
Hamilton, Ontario
Spain2 sites
San Augustin De Aviles Hospital
Avilés, 33401
University Hospital Virgen del Rocio
Seville, 41013
About this study
Official title: 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
Read the 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.
- Conditions
- Hernia
- Keywords
- Herniorrhaphy
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation Group | Subjects who meet the inclusion/exclusion criteria who have had a hernia repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of the hernia
Measured: 1 month, 6-months, 12 months, 2 years
Pain assessment scores by patients for the duration of the registry (Acute pain and Chronic pain)
Measured: 1 month, 6-months, 12 months, 2 years
Secondary outcomes (2)
Assessment of post-operative complications/safety
Measured: At the time of surgery
Assessment of procedure time
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study start1 Sep 2007
- Primary completion24 Apr 2019
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niels-Derrek Schmitz, M.D., Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622583
- Sponsor's protocol ID
- 200-06-007
- Acronym
- IHMR
- Status last verified
- Jun 2023
- First submitted
- 14 Feb 2008
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
- ClinicalTrials.gov ID
- NCT00622583
- Acronym / sponsor ID
- IHMR / 200-06-007
- Conditions
- Hernia
- Keywords
- Herniorrhaphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,179 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2007 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation Group | – | –Subjects who meet the inclusion/exclusion criteria who have had a hernia repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic and patients of the investigators at local clinics or hospitals.
Key inclusion criteria (8 listed)
- Provide written informed consent prior to surgery;
- Male or female patients that are > 18 years of age;
- Be literate and able to understand a language available in the Registry Patient Questionnaires;
- 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;
- Agree to provide long-term, outcomes data to Quintiles Outcome;
Key exclusion criteria (15 listed)
- Patients who meet any of the following criteria will be excluded from participating in the registry:
- 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 (defined as suffering pain for greater than 3 months);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of the hernia
Time frame: 1 month, 6-months, 12 months, 2 years
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
2 secondary outcomes
Assessment of post-operative complications/safety
Time frame: At the time of surgery
Assessment of procedure time
Time frame: At the time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels-Derrek Schmitz, M.D. study director
Ethicon, Inc.
54 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, run by Ethicon, Inc. at 54 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, France, United Kingdom, Australia, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of the hernia (time frame: 1 month, 6-months, 12 months, 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023; AzTrials last refreshed its copy on 29 Oct 2026.