Study of Surgical Mesh for Inguinal Hernia Repair
Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique
1 other identifier
interventional
25
1 country
2
Brief Summary
The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedOctober 4, 2010
October 1, 2010
1.3 years
June 17, 2009
October 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Technical success with no complications through 6 weeks.
6 weeks
Secondary Outcomes (3)
Hernia recurrence
1 year
Pain and functional status
10 day, 6 weeks, 6 months 1 year
Incidence of complications
10 days, 6 weeks, 6 months, 1 year
Interventions
Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.
Eligibility Criteria
You may qualify if:
- male ≥19 years old
- symptomatic and palpable inguinal hernia
- candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
- will comply with required follow-up study visits
- willing and able to provide written informed consent
You may not qualify if:
- BMI ≥35
- life expectancy of \<3 years
- strangulated hernia
- urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
- active abdominal surgical condition such as bowel obstruction or perforation
- local or systemic infection or peritonitis
- known disease that impairs wound healing
- anti-platelet therapy (other than aspirin) for \>7 days preceding the surgical procedure
- previous ipsilateral groin incision
- receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area
- uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
- advanced cirrhosis with Child-Turcott Class of C or higher
- severe COPD requiring home oxygen
- diagnosed with chronic pain syndrome or is undergoing treatment for pain management
- candidate for another major surgical procedure with the inguinal hernia repair
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biomerixlead
Study Sites (2)
Creighton University
Omaha, Nebraska, 68178, United States
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samir S Awad, MD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 19, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2010
Study Completion
November 1, 2010
Last Updated
October 4, 2010
Record last verified: 2010-10