Status
Conditions
Treatments
About
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.
Full 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 Low- and Middle-Income countries. Before and during a district hospital visit by a senior surgeon (at least once a year), a call will be made to the community, as is current practice (e.g., leaflet, radio, verbal at mosques, churches, market places, etc.).
Patients will attend the local district hospital on specific dates, which are contained within the announcement. A fully trained surgeon will examine the patient and identify patients according to the eligibility criteria, and if confirmed as eligible, they will be invited to enter the trial and consent obtained. If patients are not eligible for the trial, their care will follow the usual pathways.
After patient eligibility has been confirmed and informed consent has been obtained, patients will be randomised into the TIGER trial by a member of the TIGER research team at the site. Patients will be randomised to an operating list: NSP or surgeon list. The operating lists will be performed at the same hospital where the patient is randomised.
Patients are randomised to either of the following:
Intervention: Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) through an accredited training programme prior to commencing participation in the study.
Control: Mesh inguinal hernia repair performed by fully trained surgeons, recognised by the Ghana College of Surgeons and Physicians and other recognised Surgical Colleges around the globe.
A 'random element' will be included in the minimisation algorithm, so that each patient has a probability (unspecified here) of being randomised to a different intervention that they would have otherwise received.
Sample size: A sample size of 1782 patients (891 patients per arm) will be required to detect a non-inferiority margin of 2.5% in safe surgery, assuming a 90% baseline rate of safe surgery in the control arm (i.e., 10% of the patients are expected to have SSI or reoperation or recurrence in the control group). This allows for a 15% loss to follow-up, death before the primary outcome assessment, and misdiagnosis of inguinal hernia.
Inclusion Criteria
Exclusion Criteria
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
1,782 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Rachel Lillywhite, BA; Divya Kapoor
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal