International Hernia Mesh Registry - Full Text View

Sponsored by:	Ethicon, Inc.
Information provided by:	Ethicon, Inc.
ClinicalTrials.gov Identifier:	NCT00622583

Purpose

To determine patient reported long-term outcomes, and post-implantation clinical characteristics related to the use of mesh products in approximately 3,000 patients.

Condition
Hernia

MedlinePlus related topics: Hernia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Five-Year Follow-up, Post-Implantation, Multi-Center, International Hernia Mesh Registry

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:

Recurrence of the hernia [ Time Frame: 1 month, 6-months, 12 months, 2 years, 3 years, 4 years, 5 years ] [ Designated as safety issue: No ]
Pain assessment scores by patients for the duration of the registry (Acute pain and Chronic pain) [ Time Frame: 1 month, 6-months, 12 months, 2 years, 3 years, 4 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intraoperative handling characteristics for each ETHICON mesh product [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
Assessment of post-operative complications/safety [ Time Frame: At the time of surgery ] [ Designated as safety issue: Yes ]
Assessment of procedure time [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Observation Group Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

Provide written informed consent;
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 mesh product for repair of a hernia defect;
Agree to provide long-term, outcomes data to Outcome Sciences, Inc;
Agree to provide contact information.

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 utilizing more than one mesh or device, except bilateral inguinal or femoral, if operated on the same day. However one mesh can be two or more pieces sewn together.
Patients requiring any other (concomitant) surgical procedure;
Patients suffering from an ongoing infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622583

Contacts

Contact: Dorella Simpkins

908 218-2092

dsimpkin@ethus.jnj.com

Show 21 Study Locations

Sponsors and Collaborators

Ethicon, Inc.

Investigators

Study Director:	L. Thomas Divilio, M.D.	Ethicon, Inc.
Study Director:	Petra Koehler, M.D.	Ethicon, Inc.

More Information

Responsible Party:	ETHICON ( L. Thomas Divilio, MD )
Study ID Numbers:	200-06-007
Study First Received:	February 14, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00622583
Health Authority:	United States: Institutional Review Board; Canada: Ethics Review Committee; Italy: Ethics Committee; Germany: Ethics Commission; Belgium: Institutional Review Board; Spain: Ethics Committee; United Kingdom: Research Ethics Committee; France: Institutional Ethical Committee; Sweden: Regional Ethical Review Board

Keywords provided by Ethicon, Inc.:

Herniorrhaphy

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia

ClinicalTrials.gov processed this record on January 16, 2009