Inguinal HerniaTIGERNCT06165133
Task Sharing in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians
A study testing Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) and Mesh inguinal hernia repair performed by fully trained surgeons in people with Inguinal Hernia, run by University of Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) and Mesh inguinal hernia repair performed by fully trained surgeons
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,782 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Task Shifting in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians. A Multicentre Randomised Controlled Non-inferiority 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.
Read the 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.
Control: 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.
A 'random element' will be included in the minimisation algorithm, so that each patient has a probability (unspecified here) of being randomised to a different intervention that they would have otherwise received.
Sample size: A sample size of 1782 patients (891 patients per arm) will be required to detect a non-inferiority margin of 2.5% in safe surgery, assuming a 90% baseline rate of safe surgery in the control arm (i.e., 10% of the patients are expected to have SSI or reoperation or recurrence in the control group). This allows for a 15% loss to follow-up, death before the primary outcome assessment, and misdiagnosis of inguinal hernia.
Inclusion Criteria
- Patients older than 18 years (male or female) and less or equal to 60 years (this criteria will be made country-specific. Each country will decide the lower and upper age limit for the trial),
- 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
- 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
- Conditions
- Inguinal Hernia
- Being tested
- Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP), Mesh inguinal hernia repair performed by fully trained surgeons
- Keywords
- surgery, global surgery, inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Mesh inguinal hernia repair performed by fully trained surgeonsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Mesh inguinal hernia repair performed by fully trained surgeons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days post-op
Secondary outcomes (10)
Surgical site infection
Surgical site infection at 30 days after surgery and 90 days after surgery (CDC criteria)
Measured: 30 and 90 days after surgery
Reoperation
Reoperation at 30 days after surgery and 90 days after surgery (as described for the primary outcome)
Measured: 30 and 90 days after surgery
Recurrence
Inguinal hernia recurrence at 90 days after surgery and one year after surgery (as described for the primary outcome)
Measured: 90 days and 1 year after surgery
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.
Measured: 1 year after surgery
Chronic postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score
Chronic postoperative inguinal pain 90 days and one year after surgery using FPS-R. This is from 0 - 10, with 0 indicating no pain, and 10 indicating extreme pain.
A score of four or more (out of ten) will be used to define chronic pain in TIGER trial.
Measured: 90 days and 1 year after surgery
Postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score
Postoperative inguinal pain at 30 days after surgery (using the Faces Pain Scale - Revised (FPS-R) score). This is from 0 - 10, with 0 indicating no pain, and 10 indicating extreme pain.
A higher score would signify a worse outcome for the patient.
Measured: 30 days after surgery
Mortality
Mortality within 30 days of surgery
Measured: Within 30 days after surgery
Duration of surgery
Duration of surgery (in minutes)
Measured: Measured intraoperatively
Senior assistance during the surgical procedure.
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: Measured intraoperatively
Costs of all treatment
Cost-effectiveness 30 days after surgery. Resource use data will be collected as part of the economic evaluation of the two arms of the trial.
The cost of mesh will be controlled across the trial. Intraoperative costs will be collected via a CRF for each operation. A hospital resource use CRF will be administered to patients at discharge to collect inpatient resource use. A resource use CRF administered to a patient at follow-up will be used to collect information on post-discharge costs. All resource use will be valued in monetary terms using unit costs/ prices where possible. Information on the costs of an inguinal hernia repair operation using a surgeon and NSP will be presented to decision makers to help set appropriate reimbursement levels for hospitals undertaking inguinal hernia repair.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jun 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, 2-arm, parallel group, assessor blinded, non-inferiority randomised controlled trial with an internal pilot.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,782 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Ghana, University of Abomey Calavi, Benin
- Responsible party
- Sponsor
- Investigators
- Aneel Bhangu, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165133
- Sponsor's protocol ID
- RG_22-106
- Acronym
- TIGER
- Status last verified
- May 2024
- First submitted
- 1 Dec 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Shifting in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians. A Multicentre Randomised Controlled Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT06165133
- Acronym / sponsor ID
- TIGER / RG_22-106
- Conditions
- Inguinal Hernia
- Keywords
- surgery, global surgery, inguinal hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,782 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Ministry of Health, Ghana, University of Abomey Calavi, Benin
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Control: 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.
A 'random element' will be included in the minimisation algorithm, so that each patient has a probability (unspecified here) of being randomised to a different intervention that they would have otherwise received.
Sample size: A sample size of 1782 patients (891 patients per arm) will be required to detect a non-inferiority margin of 2.5% in safe surgery, assuming a 90% baseline rate of safe surgery in the control arm (i.e., 10% of the patients are expected to have SSI or reoperation or recurrence in the control group). This allows for a 15% loss to follow-up, death before the primary outcome assessment, and misdiagnosis of inguinal hernia.
Inclusion Criteria
- Patients older than 18 years (male or female) and less or equal to 60 years (this criteria will be made country-specific. Each country will decide the lower and upper age limit for the trial),
- 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
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, 2-arm, parallel group, assessor blinded, non-inferiority randomised controlled trial with an internal pilot.
| Arm | Type | Receives |
|---|---|---|
| Non-Surgeon Physician | Experimental | Other: Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP)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. |
| Control: Surgeon | Placebo comparator | Other: Mesh inguinal hernia repair performed by fully trained surgeonsThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP)Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) through an accredited training programme prior to commencing participation in the study | Other | Non-Surgeon Physician |
| Mesh inguinal hernia repair performed by fully trained surgeonsMesh 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. | Other | Control: Surgeon |
Primary outcome
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.
10 secondary outcomes
Surgical site infection
Time frame: 30 and 90 days after surgery
Reoperation
Time frame: 30 and 90 days after surgery
Recurrence
Time frame: 90 days and 1 year after surgery
Quality of life (assessed using Abdominal Hernia-Q)
Time frame: 1 year after surgery
Chronic postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score
Time frame: 90 days and 1 year after surgery
Postoperative inguinal pain after surgery using the Faces Pain Scale - Revised (FPS-R) score
Time frame: 30 days after surgery
Mortality
Time frame: Within 30 days after surgery
Duration of surgery
Time frame: Measured intraoperatively
Senior assistance during the surgical procedure.
Time frame: Measured intraoperatively
Costs of all treatment
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No. Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aneel Bhangu principal investigator
University of Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Mesh inguinal hernia repair performed by Non-Surgeon Physicians (NSP) and Mesh inguinal hernia repair performed by fully trained surgeons in people with Inguinal Hernia, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Lillywhite, BA (+44 7739743528, r.e.lillywhite@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety 90 days after surgery, defined by the absence of surgical site infection (SSI), reoperation or recurrence (time frame: 90 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.