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Task sharing in paediatric inguinal hernia surgery

Outcomes of paediatric inguinal hernia surgery performed by surgeons versus medical officers - a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88364607
Enrollment
341
Registered
2024-07-12
Start date
2024-07-16
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal hernia Surgery

Interventions

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 l

Sponsors

Karolinska Institutet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Occurrence of any postoperative complication assessed through patient/caregiver interview and physical examination at 2 weeks follow up

Secondary

MeasureTime frame
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

Countries

Uganda

Contacts

Public ContactJenny Löfgren
jenny.lofgren@ki.se+46 (0)8 524 80000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026