Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
NCT ID: NCT01877122
Last Updated: 2015-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2013-04-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Proflex® Mesh
Device: Partially absorbable lightweight mesh Intervention: Mesh implantation
Proflex® Mesh Mesh implantation
Implantation of mesh in the incision of inguinal area
Marlex® Mesh
Device: Non-absorbable Heavyweight mesh Intervention: Mesh implantation
Marlex® Mesh Implant
Interventions
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Proflex® Mesh Mesh implantation
Implantation of mesh in the incision of inguinal area
Marlex® Mesh Implant
Eligibility Criteria
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Inclusion Criteria
2. Patients with Unilateral hernia
3. Patients without previous operations in lower part of abdomen
4. Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form
5. Patients capable to participate during the period of the trial
Exclusion Criteria
2. Incarcerated hernia
3. Strangulated hernia
4. Patients to whom and open surgery cannot be indicated
5. Previous urological surgery
6. Immune incompetence of patient: AIDS, vesical fibrosis, etc.
7. Patients with AIHD or patients who take immunosuppressive drugs
8. Patients with liver disease (ASL, AST ≥ normal value by more than 3 times)
9. Patients with kidney disease (creatinine\>2.0mg/dL)
10. Patients on anti-coagulants
11. Patients with severe systematic disease
12. Patients with malignant tumor
13. Patients with infection or with the predicted problem of surgery site healing
14. Participation in another clinical study within the last 30 days
15. Patients whose participation is considered inappropriate according to other except above mentioned clinical condition
20 Years
85 Years
MALE
No
Sponsors
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Samyang Biopharmaceuticals Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Taeil Son, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Eulji Medical Center
Locations
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Samyang Biopharmaceuticals
Seoul, , South Korea
Countries
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Other Identifiers
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MS1-1004
Identifier Type: -
Identifier Source: org_study_id
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