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Completed

NCT Number: NCT01877122

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

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.

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

20 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Samyang Biopharmaceuticals

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male patients >=20 years =<85 years old
  • Patients with Unilateral hernia
  • Patients without previous operations in lower part of abdomen
  • Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form
  • Patients capable to participate during the period of the trial

Exclusion criteria

  • Previous hernia repair at the same site
  • Incarcerated hernia
  • Strangulated hernia
  • Patients to whom and open surgery cannot be indicated
  • Previous urological surgery
  • Immune incompetence of patient: AIDS, vesical fibrosis, etc.
  • Patients with AIHD or patients who take immunosuppressive drugs
  • Patients with liver disease (ASL, AST ≥ normal value by more than 3 times)
  • Patients with kidney disease (creatinine>2.0mg/dL)
  • Patients on anti-coagulants
  • Patients with severe systematic disease
  • Patients with malignant tumor
  • Patients with infection or with the predicted problem of surgery site healing
  • Participation in another clinical study within the last 30 days
  • Patients whose participation is considered inappropriate according to other except above mentioned clinical condition

Treatment and study plan

Proflex® Mesh Mesh implantation

Device

Implantation of mesh in the incision of inguinal area

Marlex® Mesh Implant

Device

Primary outcomes

  1. pain score (10-point Visual Analogue Scale)

    Time frame: Day90 after operation

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 13, 2013
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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