Status:
COMPLETED
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Conditions:
Hernia, Inguinal
Eligibility:
MALE
20-85 years
Phase:
PHASE4
Brief Summary
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devi...
Eligibility Criteria
Inclusion
- Male patients \>=20 years =\<85 years old
- Patients with Unilateral hernia
- Patients without previous operations in lower part of abdomen
- Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form
- Patients capable to participate during the period of the trial
Exclusion
- Previous hernia repair at the same site
- Incarcerated hernia
- Strangulated hernia
- Patients to whom and open surgery cannot be indicated
- Previous urological surgery
- Immune incompetence of patient: AIDS, vesical fibrosis, etc.
- Patients with AIHD or patients who take immunosuppressive drugs
- Patients with liver disease (ASL, AST ≥ normal value by more than 3 times)
- Patients with kidney disease (creatinine\>2.0mg/dL)
- Patients on anti-coagulants
- Patients with severe systematic disease
- Patients with malignant tumor
- Patients with infection or with the predicted problem of surgery site healing
- Participation in another clinical study within the last 30 days
- Patients whose participation is considered inappropriate according to other except above mentioned clinical condition
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01877122
Start Date
April 1 2013
End Date
December 1 2014
Last Update
June 25 2015
Active Locations (1)
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1
Samyang Biopharmaceuticals
Seoul, South Korea