Inguinal hernia Digestive System Inguinal hernia
Conditions
Interventions
A computer-based program will be used for the randomisation. Blocks of 4, 6 and 8 will be when generating the sequence. Randomisation will be done at inclusion in the study for the trainees and immedi
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Trainees: 1. Employed as intern doctor/recently completed internship in a Ugandan hospital 2. Interest in surgery 3. Willingness to participate in the study Patients: 1. Adult men 18 years and above, (this is the age of consent and below 15 years of age the body is still growing making it inappropriate to use mesh repair) 2. Primary, reducible groin hernia 3. ASA class 1 and 2 (47) 4. Willingness to participate in the study and ability to give a written informed consent
Exclusion criteria
Exclusion criteria: Trainees: 1. Does not meet the inclusion criteria Patients: 1. Recurrent hernia 2. Incarcerated groin hernia requiring emergency operation 3. Known coagulopathy (including medically induced, but not including daily usage of low-dose aspirin) 4. Obvious alcohol or substance abuse. Only obvious drug and alcohol abuse is an exclusion criterion. Signs can range between the individual being drunk, smelling of alcohol and being in poor general condition. For the latter, it can be expected that they will belong to ASA class 3 or higher which in itself is an exclusion criterion. Lab tests will not be used to diagnose drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of procedures needed to reach competence to independently perform inguinal hernia repair. Measured during the training intervention and filled out in a questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postoperative complications measured through interview and physical examination 2-4 weeks postoperatively 2. Hernia recurrence measured through physical examination 1 year and 3-5 years postoperatively 3. Chronic pain, quality of life and patient satisfaction measured through questionnaire-based interviews and physical examination at 1 year and 3-5 years postoperatively 4. Trainee rating of the training experience measured at the finalisation of training intervention using questionnaires 5. Trainee ability to name anatomical structures on the model and in a patient, measured during the training intervention using questionnaires filled out by the trainer 6. Number of procedures needed to perform a hernia repair on the model to reach proficiency on the model measured during training and filled out by the trainer in a questionnaire 7. Number of procedures performed during 12 months after the training intervention, self-reported by trainees in a questionnaire, 1 year after the training intervention 8. Trainee skill retention 1 year after the training intervention, assessed by the trainer using a questionnaire, 1 year after the training intervention 9. Rating of the training experience by the trainers, measured through a questionnaire at the end of the training intervention 10. Cost of the training intervention and cost per surgery measured by including direct and indirect costs from the trainer and health care provider's perspective. Measured at the time of the implementation of the surgical training program. 11. Cost-effectiveness of the training intervention expressed in cost per trainee to reach proficiency, cost-effectiveness of surgical procedure expressed as cost per disability-adjusted life year (DALY) averted. Costs measured as 10 (above). Training effectiveness = same as the primary outcome. DALYs calculated based on information from 3 above, measured using a questionnaire (EQ5D-3L) preoperatively compared to 2 weeks, 1 year and 3-5 years postoperatively. | — |
Countries
Uganda
Outcome results
None listed