Clinical trial NCT06165133: Task Sharing in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians
Official title: Task Shifting in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians. A Multicentre Randomised Controlled Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Keywords: surgery
global surgery
inguinal hernia
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Ghana
name: University of Abomey Calavi, Benin
First posted: 2023-12-11
Enrollment: 1782
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre, 2-arm, parallel group, assessor blinded, non-inferiority randomised controlled trial with an internal pilot.
Primary purpose: OTHER

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 mesh inguinal hernia repair compared to fully trained surgeons in adult patients with non-complicated inguinal hernia.

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 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

* Patients older than 18 years (male or female) and less or equal to 60 years (this criteria will be made country-specific. Each country will decide the lower and upper age limit for the trial),
* 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

Eligibility criteria: 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

Primary outcomes:
measure: Safety 90 days after surgery, defined by the absence of surgical site infection (SSI), reoperation or recurrence
timeFrame: 90 days post-op
Secondary outcomes:
measure: Surgical site infection
timeFrame: 30 and 90 days after surgery
measure: Reoperation
timeFrame: 30 and 90 days after surgery
measure: Recurrence
timeFrame: 90 days and 1 year after surgery
measure: Quality of life (assessed using Abdominal Hernia-Q)
timeFrame: 1 year after surgery
measure: Chronic postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score
timeFrame: 90 days and 1 year after surgery
measure: Postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score
timeFrame: 30 days after surgery
measure: Mortality
timeFrame: Within 30 days after surgery
measure: Duration of surgery
timeFrame: Measured intraoperatively
measure: Senior assistance during the surgical procedure.
timeFrame: Measured intraoperatively
measure: Costs of all treatment
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Birmingham
name: Aneel Bhangu
role: PRINCIPAL_INVESTIGATOR
References: