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

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ClinicalTrials.gov Identifier: NCT01877122
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

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 devices at 3 months follow-up.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Device: Proflex® Mesh Mesh implantation Device: Marlex® Mesh Implant Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877122


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

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01877122     History of Changes
Other Study ID Numbers: MS1-1004
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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