International Hernia Mesh Registry



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:September 1, 2007
End Date:December 1, 2021
Contact:Christine Romanowski
Email:cromanow@its.jnj.com
Phone:+1 908 218-3156

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

To determine patient reported long-term outcomes, and post-implantation clinical
characteristics related to the use of mesh products in 3,500 patients minimum.

To help identify best practices leading to lower recurrence rates and decreases in chronic
pain associated with the hernia repair procedure.

Inclusion Criteria:

- Provide written informed consent prior to surgery;

- Male or female patients that are greater than or equal to 18 years of age

- Be literate and able to understand a language available in the Registry Patient
Questionnaires;

- Be scheduled to receive a surgically implanted synthetic mesh product 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 manufacturer mesh product sewn together will be
considered as one mesh, and is therefore allowed in this registry

Exclusion Criteria:

- 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;

- 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;

- 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 scheduled to receive a surgically implanted biologic mesh product for repair
of a hernia defect;
We found this trial at
20
sites
Hicksville, New York 11801
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400
Celebration, Florida 34747
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Celebration, FL
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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Norfolk, Virginia 23507
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Norfolk, VA
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Sacramento, California 95814
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Sacramento, CA
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104 Jesse Hall
Columbia, Missouri 65211
(573) 882-2121
University Of Missouri-Columbia The University of Missouri was founded in 1839 in Columbia, Mo., as...
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Columbia, MO
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Duncanville, Texas 75116
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Duncanville, TX
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Fayetteville, North Carolina 28304
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Fayetteville, NC
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Houston, Texas 77098
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Houston, TX
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Jefferson City, Missouri 65101
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Jefferson City, MO
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Lansdale, Pennsylvania 19446
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Lansdale, PA
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New York, New York 10028
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New York, NY
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Norwood, Massachusetts 02062
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Norwood, MA
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Oklahoma City, Oklahoma 73109
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Oklahoma City, OK
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Pinehurst, North Carolina 28374
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Pinehurst, NC
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Portland, Oregon 97210
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Portland, OR
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Sarasota, Florida 34139
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Sarasota, FL
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Wilmington, North Carolina 28403
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Wilmington, NC
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Woodville, South Australia 5011
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Woodville,
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