Simulation-based training for groin hernia repair in Sierra Leone
| ISRCTN | ISRCTN14168492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14168492 |
| Secondary identifying numbers | 1 |
- Submission date
- 22/08/2023
- Registration date
- 01/09/2023
- Last edited
- 09/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
The surgical human resource is a limiting factor in meeting the demands for surgical services in low-income settings. Groin hernia represents a common surgical condition and its repair is among the most commonly performed surgical procedures worldwide. Still, the number of procedures performed needs to increase drastically in order to meet the need for this procedure. In this study, trainees enrolled in the CapaCare surgical training program in Sierra Leone will participate in a simulation-based course in inguinal hernia repair.
The aim of the study is to investigate if the learning curve to learn how to perform inguinal hernia repair on patients is affected as a result of first learning how to perform this procedure on 3D models.
Who can participate?
Trainees enrolled in the CapaCare surgical training program in Sierra Leone.
What does the study involve?
The trainees will participate in the course which includes theory and practice. They will learn how to perform a sutured inguinal hernia repair on the 3D models and will be assessed for proficiency by the researchers. After completion of the course, they will report in an electronic format about the patients that they operated on as part of their training program. This reporting is routinely done by the trainees in the CapaCare surgical training program.
What are the possible benefits and risks of participating?
The participants will benefit as they learn how to perform this procedure, step-by-step, on a 3D model under supervision prior to operating on patients. There are no direct risks associated with participating in this study.
Where is the study run from?
Masanga Hospital (Sierra Leone)
When is the study starting date and how long is it expected to run for?
March 2019 to December 2027
Who is funding the study?
The Swedish Research Council (Sweden)
Who is the main contact?
Dr Jenny Löfgren, jenny.lofgren@ki.se
Contact information
Principal Investigator
Department of Molecular Medicine and Surgery
Karolinska Institutet
Karolinska University Hospital, L1:00
Stockholm
17176
Sweden
 ORCID ID |
0000-0001-5884-0369 |
|---|---|
| Phone | +46 (0)704 612426 |
| jenny.lofgren@ki.se |
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Training facility/simulation |
| Study type | Other, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Model-based training for groin hernia repair in Sierra Leone |
| Study objectives | Does model-based training for inguinal hernia repair influence the time to stabilisation of operation time? |
| Ethics approval(s) |
Approved 01/03/2020, Sierra Leone Ethics and Scientific Review Committee (Ministry of Health and Sanitation, Directorate of Training and Research, 5th floor, Youyi Building Brookfields, Freetown, 00000, Sierra Leone; +232 (0)78 366493; efoday@health.gov.sl), ref: SLESRC (Bolkan) |
| Health condition(s) or problem(s) studied | Inguinal hernia |
| Intervention | In this study, trainees will participate in a simulation-based training program for inguinal hernia repair which includes theory and practice. They will learn how to perform a sutured inguinal hernia repair on the 3D models and will be assessed for proficiency by the researchers. After completion of the course, they will report in an electronic format about the patients that they operated on as part of their training program. This reporting is routinely done by the trainees in the CapaCare surgical training program. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Stabilisation of operation time measured through self-reported procedures carried out by the trainees after completion of the training program |
| Secondary outcome measures | 1. Postoperative complications in-hospital, self-reported by trainees in an online system. Measured continuously 2. Ability to name anatomical structures measured during training by trainers 3. Trainee and trainer impression of the model-based training, measured at the end of the training by filling out a questionnaire 4. Number of attempts to passing score on the Operative Performance Rating System (OPRS), measured during training by the trainers 5. Time to passing score on the OPRS, measured during the training by the trainers (data course started - date of examination) 6. Score on the OPRS measured during training and noted in questionnaire by the trainers 7. Cost and cost-effectiveness of the training intervention - costs calculated with the perspective of the training program, effectiveness expressed as time to reach stability of operation time. Costs are measured at the time of the training intervention. |
| Overall study start date | 01/03/2019 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Trainees in the CapaCare training program in Sierra Leone |
| Key exclusion criteria | Unwillingness to participate and sign informed consent |
| Date of first enrolment | 01/12/2022 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Sierra Leone
Study participating centre
Masanga
PO Box – 44 Magburaka
Sierra Leone
Sponsor information
University/education
Department of Molecular Medicine and Surgery
Karolinska University Hospital, L1:00
Stockholm
17176
Sweden
| Phone | +46 (0)8 524 800 000 |
|---|---|
| anders.franco-cereceda@ki.se | |
| Website | https://ki.se |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results from the study will be published in one or more publication in peer reviewed journals. Results will also be presented at conferences. |
| IPD sharing plan | Metadata will be openly accessible through Karolinska Institutet. Raw data can be made accessible through the primary investigator given appropriate ethical approvals are in place. The name and email address of the investigator/body who should be contacted for access to the datasets: Jenny Löfgren, jenny.lofgren@ki.se. The type of data that will be shared: de-identified data including number of attempts to reach proficiency, score on OPRS. Dates of availability: after study completion. Whether consent from participants was required and obtained: participants have given written informed consent. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 29/08/2023 | No | No |
Additional files
Editorial Notes
09/01/2025: The intention to publish date was changed from 01/06/2025 to 01/06/2027.
08/01/2025: The following changes were made:
1. The overall study end date was changed from 31/12/2025 to 31/12/2027.
2. The recruitment end date was changed from 31/12/2024 to 31/12/2026.
10/09/2024: The contact confirmed the record is up to date.
29/08/2023: Study's existence confirmed by the Sierra Leone Ethics and Scientific Review Committee.
