A comparative clinical equivalence study of Trulene® and Prolene® polypropylene mesh in patients undergoing Lichtenstein open repair of primary inguinal hernia secured with sutures at 6 and 12 months

Phase 4

Completed

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2020/02/023307
• Lead Sponsor: Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-11-06
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 132

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified