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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP)
Other interventionMesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) through an accredited training programme prior to commencing participation in the study
Mesh inguinal hernia repair performed by fully trained surgeons
Other interventionMesh 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.
Treatment groups
1,782 Participants
are divided into 2 treatment groupsGroup A: Non-Surgeon PhysicianExperimental treatment 1 intervention
Group B: Control: SurgeonPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
90 days post-opSecondary outcomes
1
Surgical site infection
Surgical site infection at 30 days after surgery and 90 days after surgery (CDC criteria)
Time frame
30 and 90 days after surgery2
Reoperation
Reoperation at 30 days after surgery and 90 days after surgery (as described for the primary outcome)
Time frame
30 and 90 days after surgery3
Recurrence
Inguinal hernia recurrence at 90 days after surgery and one year after surgery (as described for the primary outcome)
Time frame
90 days and 1 year after surgery4
Quality of life (assessed using Abdominal Hernia-Q)
Quality of life at one year after surgery (using the Abdominal Hernia-Q questionnaire (AHQ)). (The AHQ is a validated patient reported outcome to assess hernia-specific quality of life in patients undergoing hernia operation. The pre-operative minimum score is 8 and post-operative is 16. The pre-operative maximum score is 32 and post-operative is 64; additional questions are asked after the operation relating to satisfaction around clinical care. Lower scores indicate a patient who is in greater pain/suffering greater disruption/dysphoria attributed to their hernia or dissatisfaction with their clinical care, high scores indicate the converse.
Time frame
1 year after surgeryLocations
Sponsors and contacts
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University of Birmingham
Lead sponsor
Ministry of Health, Ghana
Collaborator
University of Abomey Calavi, Benin
Collaborator
Source ClinicalTrials.gov
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