Task Sharing in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians
ConditionInguinal Hernia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Birmingham
About this trial
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 mesh inguinal hernia repair compared to fully trained surgeons in adult patients with non-complicated inguinal hernia.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP)
- Mesh inguinal hernia repair performed by fully trained surgeons
Treatment groups
1,782 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of Birmingham
Lead sponsor
Ministry of Health, Ghana
Collaborator
University of Abomey Calavi, Benin
Collaborator
Source ClinicalTrials.gov