Task sharing in paediatric inguinal hernia surgery
| ISRCTN | ISRCTN88364607 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88364607 |
| Secondary identifying numbers | 2 |
- Submission date
- 28/06/2024
- Registration date
- 12/07/2024
- Last edited
- 09/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
Current practice in groin hernia surgery for children in Uganda includes widely implemented task sharing as the surgeries are carried out by paediatric surgeons, general surgeons and medical doctors without formal surgical training after medical school and internship. The safety and effectiveness of this practice is not known. The study aims to assess the safety and effectiveness of task sharing in paediatric groin hernia surgery in Uganda.
Who can participate?
Children aged 1-12 years old, with reducible, primary, groin hernia and who are otherwise healthy (ASA 1-2) and where parents and child are willing to give informed consent and assent (children aged 8 years old and above).
What does the study involve?
The study involves a surgical procedure (inguinal hernia repair) performed by a consultant surgeon (non-paediatric surgeon) or a medical doctor (non-surgeon). It also involves interviews and physical examination before the surgery, at discharge from the hospital, after two weeks and after one year. Safety is the primary outcome and is defined as the occurrence of any postoperative complication at 2 weeks postoperatively. Secondary outcomes include hernia recurrence, patient satisfaction, chronic pain and quality of life one year postoperatively.
What are the possible benefits and risks of participating?
The main benefit of participating in the study is that the study participants will receive a groin hernia at no cost and will be followed up to detect any complications or recurrence. The study team will manage all unwanted outcomes after the surgery. Surgery is associated with certain risks but these risks are not elevated as a result of the study.
Where is the study run from?
The study is run from Uganda in three different hospitals - Soroti and Mubende Regional Referral Hospitals and Hope and Healing Centre outside Iganga town.
When is the study starting and how long is it expected to run for?
January 2020 to December 2030
Who is funding the study?
1. The Swedish Research Council
2. The Swedish Society of Medicine
Who is the main contact?
Dr Jenny Löfgren, jenny.lofgren@ki.se
Contact information
Public, Scientific, Principal Investigator
Department of Molecular Medicine and Surgery
Karolinska University Hospital
L1:00
Stockholm
19176
Sweden
 ORCID ID |
0000-0001-5884-0369 |
|---|---|
| Phone | +46 (0)8 524 80000 |
| jenny.lofgren@ki.se |
Study information
| Study design | Non-inferiority randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety |
| Scientific title | Outcomes of paediatric inguinal hernia surgery performed by surgeons versus medical officers - a randomized controlled trial |
| Study hypothesis | Medical doctors who are not surgeons can perform paediatric inguinal hernia surgery with non-inferior results compared to surgeons. |
| Ethics approval(s) |
Approved 26/06/2024, Uganda Christian University Research and Ethics Committee (Plot 67-173, Bishop Tucker Road, Mukono, PO BOX 4, Uganda; +256 (0)312 350 800/880; info@ucu.ac.ug), ref: UCUREC-2024-829 |
| Condition | Inguinal hernia |
| Intervention | Inguinal hernia surgery will be carried out. The control arm will be operated on by specialist surgeons. The intervention arm will be operated on by medical doctors who are not surgeons but who have learnt this procedure on the job and who carry out hernia surgery in children as part of their work duties. The randomization sequence will be generated online using blocks of 4, 6, and 8. The study number and randomization arm will be written on identical pieces of paper and sealed in opaque envelopes. At the beginning of each operation day, the operating list will be determined. Allocation to the control (surgeon) or intervention (MS) arm will be performed by a team member who will open the envelope when the next patient on the list is taken to the operating room. This person will not be involved in the operations or the generation of the operation list. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Occurrence of any postoperative complication assessed through patient/caregiver interview and physical examination at 2 weeks follow up |
| Secondary outcome measures | 1. Patient satisfaction, level of pain (according to the Inguinal Pain Questionnaire score from 1-7), and quality of life according to EQ5D, all assessed through patient/caregiver interviews + physical examination by a medical doctor 2 weeks postoperatively 2. Recurrence, chronic pain according to IPQ (same as above), patient satisfaction ("Are you satisfied with the result of the operation"?) and quality of life according to EQ5D assessed through patient /caregiver interview + physical examination by a medical doctor 1 year postoperatively 3. Costs and cost-effectiveness from the provider's perspective expressed as cost in USD per DALY averted at one timepoint |
| Overall study start date | 01/01/2020 |
| Overall study end date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 341 |
| Participant inclusion criteria | 1. Child aged 1-12 years old 2. Primary reducible inguinal hernia 3. Otherwise healthy (ASA 1 and 2) 4. Willingness and ability of caregiver to give informed consent 5. Willingness and ability of child (8 years and above) to give informed assent |
| Participant exclusion criteria | 1. Previous surgery for inguinal hernia on the same side (i.e., recurrent hernia) 2. Comorbidity resulting in ASA classification 3 or higher 3. Irreducible/incarcerated hernia requiring emergency intervention 4. Caregiver/child not willing to participate |
| Recruitment start date | 16/07/2024 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- Uganda
Study participating centres
3-7 Moroto Road
Soroti
PO Box 289
Uganda
Mubende
PO BOX 4
Uganda
Iganga
PO Box 191
Uganda
Sponsor information
University/education
Department of Molecular Medicine and Surgery
Karolinska University Hospital
L1:00
Stockholm
17176
Sweden
| Phone | +46 (0)8-524 80000 |
|---|---|
| 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
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Swedish Society of Medicine, Swedish Medical Society, SLS
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The researchers expect to publish several papers based on this research study. The first manuscript should be ready for submission to a medical journal towards the end of 2025. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to patient confidentiality. There is no plan to share patient-level data openly and there is no ethical approval to do so. If anyone desires to assess the data, they may do so after first obtaining ethical approval from the relevant bodies in Uganda. They can contact Dr Jenny Löfgren, jenny.lofgren@ki.se, with their interest who will guide them on who to contact at the ethics board that has approved the study in Uganda. |
Editorial Notes
01/07/2024: Study's existence confirmed by Uganda Christian University Research and Ethics Committee.
