International Hernia Mesh Registry (IHMR)

Tracking Information
First Submitted Date	February 14, 2008
First Posted Date	February 25, 2008
Last Update Posted Date	January 3, 2018
Actual Study Start Date	September 1, 2007
Estimated Primary Completion Date	December 1, 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 27, 2012)	Recurrence of the hernia [ Time Frame: 1 month, 6-months, 12 months, 2 years ]; 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 ]
Original Primary Outcome Measures; (submitted: February 14, 2008)	Recurrence of the hernia [ Time Frame: 1 month, 6-months, 12 months, 2 years, 3 years, 4 years, 5 years ]; 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 ]
Change History	Complete list of historical versions of study NCT00622583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: November 17, 2010)	Intraoperative handling characteristics for each ETHICON lightweight mesh product and all biologic mesh products [ Time Frame: At the time of surgery ]; Assessment of post-operative complications/safety [ Time Frame: At the time of surgery ]; Assessment of procedure time [ Time Frame: At the time of surgery ]
Original Secondary Outcome Measures; (submitted: February 14, 2008)	Intraoperative handling characteristics for each ETHICON mesh product [ Time Frame: At the time of surgery ]; Assessment of post-operative complications/safety [ Time Frame: At the time of surgery ]; Assessment of procedure time [ Time Frame: At the time of surgery ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	International Hernia Mesh Registry
Official Title	A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
Brief Summary	To determine patient reported long-term outcomes, and post-implantation clinical characteristics related to the use of mesh products in 3,500 patients minimum.
Detailed Description	To help identify best practices leading to lower recurrence rates and decreases in chronic pain associated with the hernia repair procedure.
Study Type	Observational
Study Design	Observational Model: Other; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Primary care clinic and patients of the investigators at local clinics or hospitals.
Condition	Hernia
Intervention	Not Provided
Study Groups/Cohorts	Observation Group; Subjects who meet the inclusion/exclusion criteria who have had a hernia repair.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: December 2, 2010)	3500
Original Estimated Enrollment; (submitted: February 14, 2008)	3000
Estimated Study Completion Date	December 1, 2021
Estimated Primary Completion Date	December 1, 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria	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;
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact: Christine Romanowski +1 908 218-3156 cromanow@its.jnj.com
Listed Location Countries	Australia, Belgium, Canada, China, France, Germany, Italy, Netherlands, South Africa, Spain, Sweden, United Kingdom, United States
Removed Location Countries
Administrative Information
NCT Number	NCT00622583
Other Study ID Numbers	200-06-007
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ethicon, Inc.
Study Sponsor	Ethicon, Inc.
Collaborators	Not Provided
Investigators	Study Director: Niels D. Schmitz, M.D. Ethicon, Inc.
PRS Account	Ethicon, Inc.
Verification Date	January 2018