Status:
NOT_YET_RECRUITING
Task Sharing in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Ministry of Health, Ghana
University of Abomey Calavi, Benin
Conditions:
Inguinal Hernia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
TIGER is a multicentre, 2-arm, parallel group, assessor blinded, non-inferiority randomised controlled trial with an internal pilot to assess if non-surgeon physicians (NSPs) can effectively perform m...
Detailed Description
Adult patients (18 years old to 60 years old, men and women) with non-complicated inguinal hernias suitable for elective repair will be recruited from at least 18 representative district hospitals in ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients older than \<18 years\> (male or female) and less or equal to 60 years
- Primary inguinal hernia (unilateral) eligible for elective inguinal hernia repair
- Primary bilateral, but only one side being repaired
- Written informed consent of patient (signature or a fingerprint)
- Exclusion Criteria
- Complex inguinal hernias: recurrent, obstructive, or femoral hernias
- Bilateral inguinal hernias undergoing simultaneous repair
- Inguinal hernias needing emergent surgical repair (e.g., incarcerated)
- Patient unable to complete post-operative follow-up
Exclusion
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
1782 Patients enrolled
Trial Details
Trial ID
NCT06165133
Start Date
June 1 2024
End Date
June 30 2026
Last Update
May 30 2024
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