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

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 (TIGER)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202312573138301

Enrollment

1782

Registered

2023-12-13

Start date

2024-05-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Interventions

Non Surgeon Physician NSP

Control Surgeon

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Surgical site infection at 30 days after surgery and 90 days after surgery (CDC criteria) ;Reoperation at 30 days after surgery and 90 days after surgery (as described for the primary outcome) ;Inguinal hernia recurrence at 90 days after surgery and one year after surgery (as described for the primary outcome) ;Quality of life at one year after surgery (using the Hernia-Q questionnaire) (The Hernia-Q is a validated patient reported outcome to assess hernia-specific quality of life in patients undergoing hernia operation.) ;Chronic postoperative inguinal pain 90 days and one year after surgery Chronic postoperative inguinal pain will be assessed through a FPS-R (face pain scale - revised). A score of four or more (out of ten) will be used to define pain in TIGER trial. ;Postoperative inguinal pain at 30 days after surgery (using the Faces Pain Scale - Revised (FPS-R) score) ;Mortality within 30 days of surgery ;Duration of surgery (in minutes) ;Senior assistance during the surgical procedure. For every patient operated on, it will be recorded if the professional performing the operation (surgeon or NSP) required assistance from a senior surgeon during the procedure. This is extremely relevant to measure as it will inform trial applicability in a real-world clinical scenario, particularly in the NSP arm but also in the surgeon arm. ;Cost-effectiveness 30 days after surgery.	—

Measure

Time frame

Surgical site infection at 30 days after surgery and 90 days after surgery (CDC criteria) ;Reoperation at 30 days after surgery and 90 days after surgery (as described for the primary outcome) ;Inguinal hernia recurrence at 90 days after surgery and one year after surgery (as described for the primary outcome) ;Quality of life at one year after surgery (using the Hernia-Q questionnaire) (The Hernia-Q is a validated patient reported outcome to assess hernia-specific quality of life in patients undergoing hernia operation.) ;Chronic postoperative inguinal pain 90 days and one year after surgery Chronic postoperative inguinal pain will be assessed through a FPS-R (face pain scale - revised). A score of four or more (out of ten) will be used to define pain in TIGER trial. ;Postoperative inguinal pain at 30 days after surgery (using the Faces Pain Scale - Revised (FPS-R) score) ;Mortality within 30 days of surgery ;Duration of surgery (in minutes) ;Senior assistance during the surgical procedure. For every patient operated on, it will be recorded if the professional performing the operation (surgeon or NSP) required assistance from a senior surgeon during the procedure. This is extremely relevant to measure as it will inform trial applicability in a real-world clinical scenario, particularly in the NSP arm but also in the surgeon arm. ;Cost-effectiveness 30 days after surgery.

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Countries

Ghana

Contacts

Public ContactRachel Lillywhite

Trials Management Team Leader

r.e.lillywhite@bham.ac.uk447514800721

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026