Task Sharing in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians

NCT06165133 | Not Yet Recruiting DMC

• 1 other identifier: RG_22-106
• Study Type: interventional
• Target: 1,782
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inguinal Hernia

Keywords

surgery; global surgery; inguinal hernia

Outcome Measures

Primary Outcomes (1)

• Safety 90 days after surgery, defined by the absence of surgical site infection (SSI), reoperation or recurrence

  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.

  90 days post-op

Secondary Outcomes (10)

• Surgical site infection

  30 and 90 days after surgery

• Reoperation

  30 and 90 days after surgery

• Recurrence

  90 days and 1 year after surgery

• Quality of life (assessed using Abdominal Hernia-Q)

  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

Study Arms (2)

Non-Surgeon Physician

EXPERIMENTAL

The intervention arm is a mesh inguinal hernia repair performed by a non-surgeon physician (NSP). These are medical officers who have finished a 2-year mandatory house job. The medical officers will be trained to perform inguinal hernia repair by a certified surgical trainer in Ghana.

Other: Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP)

Control: Surgeon

PLACEBO COMPARATOR

The control is a mesh inguinal hernia repair performed by a fully trained surgeon, defined as one who is accredited as fully trained with the Ghana College of Physicians and Surgeons, West African College of Surgeons, or equivalent. A trained surgeon will be assisted by an NSP who has completed the TIGER training programme. We anticipate that at least 5-10 fully trained surgeons will take part in the control arm.

Other: Mesh inguinal hernia repair performed by fully trained surgeons

Interventions

Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) OTHER

Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) through an accredited training programme prior to commencing participation in the study

Non-Surgeon Physician

Mesh inguinal hernia repair performed by fully trained surgeons OTHER

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.

Control: Surgeon

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Birmingham: lead
• Ministry of Health, Ghana: collaborator
• University of Abomey Calavi, Benin: collaborator

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Aneel Bhangu

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Lillywhite, BA

CONTACT

+44 7739743528; r.e.lillywhite@bham.ac.uk

Divya Kapoor

CONTACT

+44 7514 800721; d.kapoor@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, 2-arm, parallel group, assessor blinded, non-inferiority randomised controlled trial with an internal pilot.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share