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

Hernia, Inguinal Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877122
• Other study ID #: MS1-1004
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2013
• Last updated: June 24, 2015
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hernia, Inguinal

Intervention

Device:
• Proflex® Mesh Mesh implantation
Implantation of mesh in the incision of inguinal area
• Marlex® Mesh Implant

Locations

Country	Name	City	State
Korea, Republic of	Samyang Biopharmaceuticals	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score (10-point Visual Analogue Scale)		Day90 after operation	No