International Hernia Mesh Registry

Completed

Conditions studied: Hernia

In brief

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

Key facts

Study ID

NCT00622583

Run by

Ethicon, Inc.

People needed

5179

Starts

2007-09-01

Expected to finish

2021-01-25

Last updated by the study team

2023-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Center for Hernia Repair — Sarasota, Florida, United States
• Steward Norwood Hospital — Norwood, Massachusetts, United States
• University of Missouri-Columbia — Columbia, Missouri, United States
• SurgiCare of Missouri, P.C. — Jefferson City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Queens Long Island Medical Group — Hicksville, New York, United States
• Laparoscopic Surgical Center of New York — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Owen Drive Surgical Clinic of Fayetteville — Fayetteville, North Carolina, United States
• Pinehurst Surgical Center — Pinehurst, North Carolina, United States
• South East Area Health Education Center (SEAHEC) — Wilmington, North Carolina, United States
• Southwest Specialty Clinics — Oklahoma City, Oklahoma, United States
• The Oregon Clinic — Portland, Oregon, United States
• North Penn Surgical Associates — Lansdale, Pennsylvania, United States
• Dallas Hernia Institute — Duncanville, Texas, United States
• Kirby Surgical Center — Houston, Texas, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Queen Elizabeth Hospital — Woodville, South Australia, Australia
• MercyCare Mount Lawley Hospital — Mount Lawley, Western Australia, Australia
• The Wesley Hospital — Auchenflower, Australia
• Imelda Hospital — Bonheiden, Belgium
• University Hospital Ghent — Ghent, Belgium
• Centre for the Advancement of Minimally Invasive Surgery (CAMIS) — Edmonton, Alberta, Canada
• Hamilton Health Sciences - General — Hamilton, Ontario, Canada
• Florida Hospital Celebration Health — Celebration, Florida, United States

Full record on ClinicalTrials.gov

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