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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01877122

Enrollment

Registered

2013-06-13

Start date

2013-04-30

Completion date

2014-12-31

Last updated

2015-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

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.

Interventions

DEVICEProflex® Mesh Mesh implantation

Implantation of mesh in the incision of inguinal area

DEVICEMarlex® Mesh Implant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
pain score (10-point Visual Analogue Scale)	Day90 after operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026