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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Samyang Biopharmaceuticals Corporation
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01877122
First received: June 5, 2013
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877122

Locations
Korea, Republic of
Samyang Biopharmaceuticals Recruiting
Seoul, Korea, Republic of
Contact: Jin       lapkoy@samyang.com   
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Investigators
Principal Investigator: Yeonsoo Chang, M.D., Ph.D. Eulji Medical Center
  More Information

No publications provided

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01877122     History of Changes
Other Study ID Numbers: MS1-1004
Study First Received: June 5, 2013
Last Updated: June 12, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 31, 2014