Task sharing in paediatric inguinal hernia surgery
- Conditions
- Inguinal herniaSurgery
- Registration Number
- ISRCTN88364607
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 341
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of any postoperative complication assessed through patient/caregiver interview and physical examination at 2 weeks follow up
- Secondary Outcome Measures
Name Time Method 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<br>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 <br>3. Costs and cost-effectiveness from the provider's perspective expressed as cost in USD per DALY averted at one timepoint<br>