Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202312573138301 Date of Registration: 13/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Task Sharing in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians (TIGER)
Official scientific title 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)
Brief summary describing the background and objectives of the 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. The aims of the internal pilot are to assess: The ability to recruit patients: assessment of the timeframe needed to recruit 100 patients, looking at excluded patients and reasons to ensure maximum enrolment of eligible patients. The feasibility of intervention delivery: proportion of patients in which a surgeon joins the NSP to complete the operation. The following measures will be used by the Trial Management Group (TMG) to adjust the trial processes of the main phase trial if required. Specific cut-offs and stop/go criteria are not given, as they would be arbitrary. Rather, the summary data will be used by the TMG to make any recommendations to the Trial Steering Committee to improve the conduct of the main phase trial. The results from the pilot trial will be published to demonstrate the applicability of the trial processes and outcome measures in low- and middle-income countries. Trial management will be provided through the Hub and Spoke network of the National Institute for Health and Care Research Global Surgery Unit (NIHR GSU). 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. Each participating hospital will develop a bespoke system to identify potentially eligible patients. 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 date
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Task-shifting
Anticipated trial start date 01/05/2024
Actual trial start date
Anticipated date of last follow up 30/04/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1782
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Non Surgeon Physician NSP N/A NSP will perform the operation Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) through an accredited training programme prior to commencing participation in the study 891
Control Group Control Surgeon n/a Surgeon will perform operation 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. 891 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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) 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 Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/12/2023 Ghana Health Service Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Research Development Division Ghana Health Service P O Box MB 190 Accra Accra HQ6VRXG Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 Outcome Surgical site infection at 30 days after surgery and 90 days after surgery (CDC criteria) 30 and 90 days after surgery
Secondary Outcome Reoperation at 30 days after surgery and 90 days after surgery (as described for the primary outcome) 30 and 90 days after surgery
Secondary Outcome Inguinal hernia recurrence at 90 days after surgery and one year after surgery (as described for the primary outcome) 90 days and 1 year after surgery
Secondary 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.) 1 year after surgery
Secondary Outcome 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. 90 days and 1 year after surgery
Secondary Outcome Postoperative inguinal pain at 30 days after surgery (using the Faces Pain Scale - Revised (FPS-R) score) 30 days after surgery
Secondary Outcome Mortality within 30 days of surgery Within 30 days after surgery
Secondary Outcome Duration of surgery (in minutes) Measured intraoperatively
Secondary Outcome 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. Measured intraoperatively
Secondary Outcome Cost-effectiveness 30 days after surgery. 30 days after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lawra District Hospital J4V6 5PW, Lawra, Ghana Lawra Ghana
Debiso District Hospital MW44 6RR, Debiso, Ghana Debiso Ghana
St Martins De Pores Hospital Eikwe Main Road, Eikwe, Ghana Eikwe Ghana
Holy Family Hospital Berekum CCW7 36J, Berekum, Ghana Berekum Ghana
Holy Family Hospital Techiman Techiman-Tamale Rd, Techiman, Ghana Techiman Ghana
Twifo Praso Government Hospital JF62 7FC, Twifo Praso, Ghana Twifo Praso Ghana
Saltpond Government Hospital 6W3V RG6, Unnamed Road, Saltpond, Ghana Saltpond Ghana
Salaga Municipal Hospital HF4M WX4, Salaga-Bimbila Rd, Salaga, Ghana Salaga Ghana
Sandema District Hospital PPM6 7RQ, Sandema, Ghana Sandema Ghana
War Memorial Hospital Navrongo box 34, Navrongo, Ghana Navrongo Ghana
Bongo District Hospital Bongo District Hospital Bongo Ghana
Sefwi Wiawso District Hospital P.O.BOX 7 SEFWI WIAWSO Wiawso Ghana
Baabiani District Hospital FM2P 428 Bibiani Ghana
St Peters Hospital Jacobu St Peters Hospital Jacobu JACOBU Ghana
SDA Hospital Agona Wiamose SDA Hospital Agona Wiamose Wiamose Ghana
SDA Hospital Kwadaso SDA Hospital Kwadaso Kwadaso Ghana
Asaman Government Hospital Asaman Asaman Government Hospital Asaman Asaman Ghana
Tamale Teaching Hospital Salaga yendi Rd, Tamale, Ghana Tamale Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute for Health and Care Research 39 Victoria Street Westminster London SW1H 0EU United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The University of Birmingham Research Governance Team University of Birmingham Birmingham B15 2TT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Professor Stephen Tabiri Tamale Teaching Hospital University for Development Studies Tamale TL1883 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aneel Bhangu a.a.bhangu@bham.ac.uk +441216272949 Institute of Translational Medicine University of Birmingham
City Postal code Country Position/Affiliation
Birmingham B15 2TT United Kingdom Professor of Global Surgery
Role Name Email Phone Street address
Public Enquiries Rachel Lillywhite r.e.lillywhite@bham.ac.uk 447514800721 BCTU University of Birmingham
City Postal code Country Position/Affiliation
Birmingham B15 2TT United Kingdom Trials Management Team Leader
Role Name Email Phone Street address
Scientific Enquiries Bryar Kadir b.kadir@bham.ac.uk 447514800721 BCTU University of Birmingham
City Postal code Country Position/Affiliation
Birmingham B15 2TT United Kingdom Senior Statistician
Role Name Email Phone Street address
Principal Investigator Stephen Tabiri stabiri@uds.edu.gh +233201691005 Unnamed Road Tamale Ghana
City Postal code Country Position/Affiliation
Tamale 94C7WW2 Ghana Professor of Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the primary publication (after de identification, i.e. text, tables, figures, and appendices) may be requested for the purpose of meta-analyses or to achieve aims in the approved protocol. To gain access, data requestors will need to sign a data access agreement. Statistical Analysis Plan,Study Protocol After primary publication for 36 months. Controlled. All data sharing requests will be reviewed by the ITMG. Any secondary publications and presentations prepared by Investigators must be reviewed and approved by the ITMG. Manuscripts must be submitted to the ITMG in a timely fashion and in advance of being submitted for publication to allow time for review and resolution of any outstanding issues. Authors must acknowledge that the trial was performed with the support of the University of Birmingham and funding from the National Institute for Health Research (including relevant acknowledgment text that will be provided by the ITMG). Individual countries will be allowed to publish their efficacy results; however, the publication of efficacy results from the pooled analysis will take precedence over efficacy result publications of individual countries unless the ITMG decides otherwise.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information