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Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair

This study has been completed.
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation Identifier:
First received: June 5, 2013
Last updated: June 24, 2015
Last verified: June 2015
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 devices at 3 months follow-up.

Condition Intervention Phase
Hernia, Inguinal Device: Proflex® Mesh Mesh implantation Device: Marlex® Mesh Implant Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)

Resource links provided by NLM:

Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • pain score (10-point Visual Analogue Scale) [ Time Frame: Day90 after operation ]

Enrollment: 50
Study Start Date: April 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proflex® Mesh
Device: Partially absorbable lightweight mesh Intervention: Mesh implantation
Device: Proflex® Mesh Mesh implantation
Implantation of mesh in the incision of inguinal area
Active Comparator: Marlex® Mesh
Device: Non-absorbable Heavyweight mesh Intervention: Mesh implantation
Device: Marlex® Mesh Implant


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male patients >=20 years =<85 years old
  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:

  1. Previous hernia repair at the same site
  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
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Please refer to this study by its identifier: NCT01877122

Korea, Republic of
Samyang Biopharmaceuticals
Seoul, Korea, Republic of
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Principal Investigator: Taeil Son, M.D., Ph.D. Eulji Medical Center
  More Information

Responsible Party: Samyang Biopharmaceuticals Corporation Identifier: NCT01877122     History of Changes
Other Study ID Numbers: MS1-1004
Study First Received: June 5, 2013
Last Updated: June 24, 2015

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017