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

Samyang Biopharmaceuticals Corporation

Status and phase: Completed; Phase 4

Conditions: Hernia, Inguinal

Treatments: Device: Proflex® Mesh Mesh implantation; Device: Marlex® Mesh Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01877122

MS1-1004

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Proflex® Mesh

Experimental group

Description:

Device: Partially absorbable lightweight mesh Intervention: Mesh implantation

Treatment:

Device: Proflex® Mesh Mesh implantation

Marlex® Mesh

Active Comparator group

Description:

Device: Non-absorbable Heavyweight mesh Intervention: Mesh implantation

Treatment:

Device: Marlex® Mesh Implant