International Hernia Mesh Registry

Hernia Clinical Trial

— IHMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622583
• Other study ID #: 200-06-007
• Status: Completed
• Start date: September 1, 2007
• Est. completion date: January 25, 2021

Study information

• Verified date: June 2023
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5179
• Est. completion date: January 25, 2021
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia

Locations

Country	Name	City	State
Australia	The Wesley Hospital	Auchenflower
Australia	MercyCare Mount Lawley Hospital	Mount Lawley	Western Australia
Australia	Queen Elizabeth Hospital	Woodville	South Australia
Belgium	Imelda Hospital	Bonheiden
Belgium	University Hospital Ghent	Gent
Canada	Centre for the Advancement of Minimally Invasive Surgery (CAMIS)	Edmonton	Alberta
Canada	Hamilton Health Sciences - General	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario
China	Huadong Hospital- Affilated to Fudan University	Shanghai
France	Hopital Prive D'Antony	Antony Cedex
France	CH Avignon - Service de Chirurgie Digestive	Avignon
France	CHU Hotel Dieu	Clermont-Ferrand
France	Hospital Saint Philibert	Lomme
France	Hopital Prive Mermoz	Lyon
France	HIA Laveran	Marseille
France	CHU de Nancy	Nancy
France	Service de Chirurgie Generale et Cancerologie Digestiv	Nice
France	Groupe Hospitalier Paris Saint-Joseph	Paris
France	Centre Hospitalier Robert Debre	Reims
Germany	Lukaskrankenhaus	Neuss
Italy	Universita Cattolica Sacro Cuore	Rome
Netherlands	Jeroen Bosch Hospital	Hertogenbosch
South Africa	New Somerset Hospital	Cape Town
Spain	San Augustin De Aviles Hospital	Aviles
Spain	University Hospital Virgen del Rocio	Sevilla
Sweden	Sodertalje Hospital	Sodertalje
United Kingdom	Ayr Hospital	Ayr
United Kingdom	Royal United Hospital	Bath	Somerset
United Kingdom	Dorset County Hospital	Dorchester
United Kingdom	Royal Bolton Hospital	Farnworth
United Kingdom	Hinchingbrooke Hospital	Huntingdon	Cambrideshire
United Kingdom	St Mary's Hospital	London
United Kingdom	North Tyneside General Hospital	North Shields
United Kingdom	Northampton General Hospital	Northampton
United Kingdom	Royal Alexandra Hospital	Paisley
United Kingdom	University Hospitals of North Midlands	Stoke- on-Trent	Staffordshire
United States	Florida Hospital Celebration Health	Celebration	Florida
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Missouri-Columbia	Columbia	Missouri
United States	Dallas Hernia Institute	Duncanville	Texas
United States	Owen Drive Surgical Clinic of Fayetteville	Fayetteville	North Carolina
United States	Queens Long Island Medical Group	Hicksville	New York
United States	Kirby Surgical Center	Houston	Texas
United States	SurgiCare of Missouri, P.C.	Jefferson City	Missouri
United States	North Penn Surgical Associates	Lansdale	Pennsylvania
United States	Laparoscopic Surgical Center of New York	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Steward Norwood Hospital	Norwood	Massachusetts
United States	Southwest Specialty Clinics	Oklahoma City	Oklahoma
United States	Pinehurst Surgical Center	Pinehurst	North Carolina
United States	The Oregon Clinic	Portland	Oregon
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Center for Hernia Repair	Sarasota	Florida
United States	South East Area Health Education Center (SEAHEC)	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  France,  Germany,  Italy,  Netherlands,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of the hernia		1 month, 6-months, 12 months, 2 years
Primary	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	Assessment of post-operative complications/safety		At the time of surgery
Secondary	Assessment of procedure time		At the time of surgery