Clinical trial NCT00622583: International Hernia Mesh Registry
Official title: A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Keywords: Herniorrhaphy
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 5179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic and patients of the investigators at local clinics or hospitals.

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

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.

Eligibility 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

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

Primary outcomes:
measure: Recurrence of the hernia
timeFrame: 1 month, 6-months, 12 months, 2 years
measure: Pain assessment scores by patients for the duration of the registry (Acute pain and Chronic pain)
timeFrame: 1 month, 6-months, 12 months, 2 years
Secondary outcomes:
measure: Assessment of post-operative complications/safety
timeFrame: At the time of surgery
measure: Assessment of procedure time
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
city: Sarasota
country: United States
facility: Center for Hernia Repair
state: Florida
city: Norwood
country: United States
facility: Steward Norwood Hospital
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
city: Jefferson City
country: United States
facility: SurgiCare of Missouri, P.C.
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hicksville
country: United States
facility: Queens Long Island Medical Group
state: New York
city: New York
country: United States
facility: Laparoscopic Surgical Center of New York
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Fayetteville
country: United States
facility: Owen Drive Surgical Clinic of Fayetteville
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Surgical Center
state: North Carolina
city: Wilmington
country: United States
facility: South East Area Health Education Center (SEAHEC)
state: North Carolina
city: Oklahoma City
country: United States
facility: Southwest Specialty Clinics
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Lansdale
country: United States
facility: North Penn Surgical Associates
state: Pennsylvania
city: Duncanville
country: United States
facility: Dallas Hernia Institute
state: Texas
city: Houston
country: United States
facility: Kirby Surgical Center
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Mount Lawley
country: Australia
facility: MercyCare Mount Lawley Hospital
state: Western Australia
city: Auchenflower
country: Australia
facility: The Wesley Hospital
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Gent
country: Belgium
facility: University Hospital Ghent
city: Edmonton
country: Canada
facility: Centre for the Advancement of Minimally Invasive Surgery (CAMIS)
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Shanghai
country: China
facility: Huadong Hospital- Affilated to Fudan University
city: Antony Cedex
country: France
facility: Hopital Prive D'Antony
city: Avignon
country: France
facility: CH Avignon - Service de Chirurgie Digestive
city: Clermont-Ferrand
country: France
facility: CHU Hotel Dieu
city: Lomme
country: France
facility: Hospital Saint Philibert
city: Lyon
country: France
facility: Hopital Prive Mermoz
city: Marseille
country: France
facility: HIA Laveran
city: Nancy
country: France
facility: CHU de Nancy
city: Nice
country: France
facility: Service de Chirurgie Generale et Cancerologie Digestiv
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
city: Reims
country: France
facility: Centre Hospitalier Robert Debre
city: Neuss
country: Germany
facility: Lukaskrankenhaus
city: Rome
country: Italy
facility: Universita Cattolica Sacro Cuore
city: Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Cape Town
country: South Africa
facility: New Somerset Hospital
city: Aviles
country: Spain
facility: San Augustin De Aviles Hospital
city: Sevilla
country: Spain
facility: University Hospital Virgen del Rocio
city: Sodertalje
country: Sweden
facility: Sodertalje Hospital
city: Huntingdon
country: United Kingdom
facility: Hinchingbrooke Hospital
state: Cambrideshire
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: Somerset
city: Stoke- on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands
state: Staffordshire
city: Ayr
country: United Kingdom
facility: Ayr Hospital
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Farnworth
country: United Kingdom
facility: Royal Bolton Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
Study officials:
affiliation: Ethicon, Inc.
name: Niels-Derrek Schmitz, M.D.
role: STUDY_DIRECTOR
References: