Task Shifting in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians. A Multicentre Randomised Controlled Non-inferiority Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Birmingham
- Enrollment
- 1,782
- Primary Endpoint
- Safety 90 days after surgery, defined by the absence of surgical site infection (SSI), reoperation or recurrence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
The primary outcome assessment 90 days after surgery will be performed by a trained member of the research team who will not have access to the patient's hospital records or notes. If additional data needs to be retrospectively retrieved from hospital notes relating to a patient's secondary outcomes, then this may be accessed by any member of the research staff at that hospital (blinded or unblinded).
The operating surgeon and patient are impossible to blind, as the patient will meet the surgeon on the day of surgery and introduce themselves. It is unethical and impractical not to tell a patient who is doing their surgery.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety 90 days after surgery, defined by the absence of surgical site infection (SSI), reoperation or recurrence
Time Frame: 90 days post-op
SSI will be defined as per CDC criteria within 90 days of inguinal hernia repair SSI after surgery will be defined according to CDC criteria. The following CDC definition will be used to identify deep incisional or superficial SSIs: Infection must occur within 30-days of the index operation AND Infection must involve the skin, subcutaneous, muscular or fascial layers of the incision AND Patient must have at least one of the following: Purulent drainage from the wound Organisms detected from a wound swab Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; systemic fever (\>38°C) Diagnosis of SSI by a clinician or radiological imaging Reoperation will be defined as any surgical complication requiring reoperation in theatre within 90 days of inguinal hernia repair. Recurrence will be defined as in the Reinforcement of Closure of Stoma Site (ROCSS) Trial.
Secondary Outcomes
- Reoperation(30 and 90 days after surgery)
- Surgical site infection(30 and 90 days after surgery)
- Postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score(30 days after surgery)
- Duration of surgery(Measured intraoperatively)
- Senior assistance during the surgical procedure.(Measured intraoperatively)
- Costs of all treatment(30 days after surgery)
- Recurrence(90 days and 1 year after surgery)
- Chronic postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score(90 days and 1 year after surgery)
- Quality of life (assessed using Abdominal Hernia-Q)(1 year after surgery)
- Mortality(Within 30 days after surgery)