CTRI/2020/02/023307
Completed
Phase 4
Single blind, randomized study comparing clinical equivalence of Trulene® and Prolene® polypropylene mesh, in subjects undergoing Lichtenstein open repair of primary inguinal hernia secured with sutures
Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd0 sites132 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd
- Enrollment
- 132
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males aged between 18\-70 years of age with good systemic/ mental health as per opinion of investigator
- •2\. Subjects with the presence of uncomplicated primary inguinal hernia requiring elective surgery with mesh fixation
- •3\. Subjects with ASA grade 1 or grade 2
- •4\. Subjects who have given written informed consent
- •5\. Subjects with no previous history of anterior mesh hernia repair
Exclusion Criteria
- •1\. Subjects with BMI \>\=35
- •2\. Subjects having life expectancy of less than one year (52 weeks) duration
- •3\. Subjects requiring emergency surgical procedures
- •4\. Subjects undergoing elective/emergency laparoscopic inguinal hernioplasty
- •5\. Subjects having active infection at or around the skin incision site
- •6\. Subjects who are unable to walk 500 meters.
- •7\. Subjects with a prior mesh in the abdominal wall
- •8\. Subjects having bilateral inguinal hernia or recurrence of hernia
- •9\. Subjects having femoral hernia and strangulated hernia
- •10\. Subjects with history of allergy to polypropylene or similar products
Outcomes
Primary Outcomes
Not specified
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