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

Phase 4

Completed

• Conditions: Hernia, Inguinal
• Interventions: Device: Marlex® Mesh Implant; Device: Proflex® Mesh Mesh implantation

• Registration Number: NCT01877122
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-13
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marlex® Mesh	Marlex® Mesh Implant	Device: Non-absorbable Heavyweight mesh Intervention: Mesh implantation
Proflex® Mesh	Proflex® Mesh Mesh implantation	Device: Partially absorbable lightweight mesh Intervention: Mesh implantation

Primary Outcome Measures

Name	Time	Method
pain score (10-point Visual Analogue Scale)	Day90 after operation

Trial Locations

Locations (1)

Samyang Biopharmaceuticals; 🇰🇷 Seoul, Korea, Republic of