Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Trulene Polypropylene Mesh: Healthium Medtech Limited
Control Intervention1: Prolene Polypropylene Mesh: Johnson & Johnson, Inc
Sponsors
Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd
Eligibility
Inclusion 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
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 11. Subjects with history of tuberculosis, intractable chronic cough, bleeding disorders, osteoporosis, unstable or life-threatening conditions, history of cancer or in the process of cancer treatment, radiotherapy in pelvic area, known immunodeficiency or immunosuppression 12. Subjects already participating in another surgical study 13. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure 14. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator 15. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center 16. Other indication-based exclusion, in opinion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the recurrence rate of hernia in both the groups at the end of 6 and 12 monthsTimepoint: 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the extent of reduction of pain in two groups To analyze the frequency of infection in the two groups To assess the short and long-term complications associated with hernioplasty in both the groups To assess the amount of time subject takes to resume back to normal activities in both the groups To assess the complications associated with mesh material in both the groups To evaluate postoperative discomfort and overall subject satisfaction score in both the groups Timepoint: day 7 month 1 month 3 month 6 month 12 | — |
Countries
India
Contacts
Public ContactDr Ashok Moharana
Healthium Medtech Pvt.Ltd. (formerly Sutures India Pvt. Ltd.)
Outcome results
None listed