Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 5, 2013
CompletedFirst Posted
Study publicly available on registry
June 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 25, 2015
June 1, 2015
1.7 years
June 5, 2013
June 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
pain score (10-point Visual Analogue Scale)
Day90 after operation
Study Arms (2)
Proflex® Mesh
EXPERIMENTALDevice: Partially absorbable lightweight mesh Intervention: Mesh implantation
Marlex® Mesh
ACTIVE COMPARATORDevice: Non-absorbable Heavyweight mesh Intervention: Mesh implantation
Interventions
Implantation of mesh in the incision of inguinal area
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samyang Biopharmaceuticals
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taeil Son, M.D., Ph.D.
Eulji Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2013
First Posted
June 13, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 25, 2015
Record last verified: 2015-06