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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 December 2012 |
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Main ID: |
NCT00681291 |
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Date of registration:
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15/05/2008 |
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Primary sponsor: |
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Public title:
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Strattice in Repair of Inguinal Hernias
RING |
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Scientific title:
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Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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172 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00681291 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Samir Awad, MD, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Name:
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Robert Fitzgibbons, MD, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Creighton University |
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Name:
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Charles Bellows, MD, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tulane University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult male
- symptomatic and palpable inguinal hernia
- open, elective, primary unilateral inguinal hernia repair
Exclusion Criteria:
- bilater inguinal hernia repair
- BMI >35
- chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes,
severe liver disease or COPD
- chronic prostatitis, orchitis, testicular pain
- local or systemic infection at time of repair
- known collagen disorder
- chronic pain syndrome or under active pain management
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hernia, Inguinal
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Intervention(s)
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Device: Inguinal hernia repair with Strattice
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Device: Inguinal hernia repair with Ultrapro
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Primary Outcome(s)
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Resumption of Activities of Daily Living
[Time Frame: Months 3, 6, 12 and 24]
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Secondary Outcome(s)
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Analgesic consumption
[Time Frame: POD 1-10, Month 3]
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Hernia recurrence
[Time Frame: Months 12 and 24]
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Incidence of chronic pain
[Time Frame: Month 12]
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Postoperative wound events
[Time Frame: POD 10 and Month 3]
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Quality and severity of pain
[Time Frame: POD 10 and Months 3, 6, 12 and 24]
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Secondary ID(s)
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LFC2007.04.01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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