International Hernia Mesh Registry

NCT00622583 | Completed

• 1 other identifier: 200-06-007
• Study Type: observational
• Target: 5,179
• Locations: 13 countries
• Sites: 54

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

Conditions

Hernia

Keywords

Herniorrhaphy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Assessment of post-operative complications/safety

  At the time of surgery

• Assessment of procedure time

  At the time of surgery

Study Arms (1)

Observation Group

Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (54)

Florida Hospital Celebration Health

Celebration, Florida, 34747, United States

Location

Center for Hernia Repair

Sarasota, Florida, 34139, United States

Location

Steward Norwood Hospital

Norwood, Massachusetts, 02062, United States

Location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

SurgiCare of Missouri, P.C.

Jefferson City, Missouri, 65101, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Queens Long Island Medical Group

Hicksville, New York, 11801, United States

Location

Laparoscopic Surgical Center of New York

New York, New York, 10028, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232, United States

Location

Owen Drive Surgical Clinic of Fayetteville

Fayetteville, North Carolina, 28304, United States

Location

Pinehurst Surgical Center

Pinehurst, North Carolina, 28374, United States

Location

South East Area Health Education Center (SEAHEC)

Wilmington, North Carolina, 28403, United States

Location

Southwest Specialty Clinics

Oklahoma City, Oklahoma, 73109, United States

Location

The Oregon Clinic

Portland, Oregon, 97225, United States

Location

North Penn Surgical Associates

Lansdale, Pennsylvania, 19446, United States

Location

Dallas Hernia Institute

Duncanville, Texas, 75116, United States

Location

Kirby Surgical Center

Houston, Texas, 77098, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

MercyCare Mount Lawley Hospital

Mount Lawley, Western Australia, 6050, Australia

Location

The Wesley Hospital

Auchenflower, QLD 4066, Australia

Location

Imelda Hospital

Bonheiden, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Centre for the Advancement of Minimally Invasive Surgery (CAMIS)

Edmonton, Alberta, T5H 1A8, Canada

Location

Hamilton Health Sciences - General

Hamilton, Ontario, L8L2X2, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, Canada

Location

Huadong Hospital- Affilated to Fudan University

Shanghai, China

Location

Hopital Prive D'Antony

Antony, France

Location

CH Avignon - Service de Chirurgie Digestive

Avignon, 84902, France

Location

CHU Hotel Dieu

Clermont-Ferrand, France

Location

Hospital Saint Philibert

Lomme, 59462, France

Location

Hopital Prive Mermoz

Lyon, 69008, France

Location

HIA Laveran

Marseille, 13384, France

Location

CHU de Nancy

Nancy, 54038, France

Location

Service de Chirurgie Generale et Cancerologie Digestiv

Nice, 06202, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Centre Hospitalier Robert Debre

Reims, 51092, France

Location

Lukaskrankenhaus

Neuss, 41464, Germany

Location

Universita Cattolica Sacro Cuore

Rome, Italy

Location

Jeroen Bosch Hospital

's-Hertogenbosch, 5223 GZ, Netherlands

Location

New Somerset Hospital

Cape Town, 8051, South Africa

Location

San Augustin De Aviles Hospital

Avilés, 33401, Spain

Location

University Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Sodertalje Hospital

Södertälje, 152 86, Sweden

Location

Hinchingbrooke Hospital

Huntingdon, Cambrideshire, PE29GNT, United Kingdom

Location

Royal United Hospital

Bath, Somerset, BA1 3NG, United Kingdom

Location

University Hospitals of North Midlands

Stoke-on-Trent, Staffordshire, ST46QG, United Kingdom

Location

Ayr Hospital

Ayr, KA6 6DX, United Kingdom

Location

Dorset County Hospital

Dorchester, DT12JY, United Kingdom

Location

Royal Bolton Hospital

Farnworth, BL4 0JR, United Kingdom

Location

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

North Tyneside General Hospital

North Shields, United Kingdom

Location

Northampton General Hospital

Northampton, United Kingdom

Location

Royal Alexandra Hospital

Paisley, PA2 9PN, United Kingdom

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Niels-Derrek Schmitz, M.D.

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 25, 2008
• Study Start: September 1, 2007
• Primary Completion: April 24, 2019
• Study Completion: January 25, 2021
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

BE (2); ES (2); IT (1); GB (10); CN (1); SE (1); DE (1); FR (10); NL (1); CA (3); ZA (1); US (18); AU (3)