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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00622583




Registration number
NCT00622583
Ethics application status
Date submitted
14/02/2008
Date registered
25/02/2008
Date last updated
5/06/2023

Titles & IDs
Public title
International Hernia Mesh Registry
Scientific title
A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
Secondary ID [1] 0 0
200-06-007
Universal Trial Number (UTN)
Trial acronym
IHMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hernia 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation Group - Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence of the hernia
Timepoint [1] 0 0
1 month, 6-months, 12 months, 2 years
Primary outcome [2] 0 0
Pain assessment scores by patients for the duration of the registry (Acute pain and Chronic pain)
Timepoint [2] 0 0
1 month, 6-months, 12 months, 2 years
Secondary outcome [1] 0 0
Assessment of post-operative complications/safety
Timepoint [1] 0 0
At the time of surgery
Secondary outcome [2] 0 0
Assessment of procedure time
Timepoint [2] 0 0
At the time of surgery

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/01/2021
Sample size
Target
Accrual to date
Final
5179
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 0 0
MercyCare Mount Lawley Hospital - Mount Lawley
Recruitment hospital [3] 0 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment postcode(s) [2] 0 0
6050 - Mount Lawley
Recruitment postcode(s) [3] 0 0
QLD 4066 - Auchenflower
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Belgium
State/province [11] 0 0
Bonheiden
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
France
State/province [16] 0 0
Antony Cedex
Country [17] 0 0
France
State/province [17] 0 0
Avignon
Country [18] 0 0
France
State/province [18] 0 0
Clermont-Ferrand
Country [19] 0 0
France
State/province [19] 0 0
Lomme
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
Nancy
Country [23] 0 0
France
State/province [23] 0 0
Nice
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Reims
Country [26] 0 0
Germany
State/province [26] 0 0
Neuss
Country [27] 0 0
Italy
State/province [27] 0 0
Rome
Country [28] 0 0
Netherlands
State/province [28] 0 0
Hertogenbosch
Country [29] 0 0
South Africa
State/province [29] 0 0
Cape Town
Country [30] 0 0
Spain
State/province [30] 0 0
Aviles
Country [31] 0 0
Spain
State/province [31] 0 0
Sevilla
Country [32] 0 0
Sweden
State/province [32] 0 0
Sodertalje
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Cambrideshire
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Somerset
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Staffordshire
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Ayr
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Dorchester
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Farnworth
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
North Shields
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Northampton
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Paisley

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ethicon, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00622583
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niels-Derrek Schmitz, M.D.
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT00622583