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Task sharing in paediatric inguinal hernia surgery

Not Applicable
Conditions
Inguinal hernia
Surgery
Registration Number
ISRCTN88364607
Lead Sponsor
Karolinska Institutet
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
341
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

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
NameTimeMethod
Occurrence of any postoperative complication assessed through patient/caregiver interview and physical examination at 2 weeks follow up
Secondary Outcome Measures
NameTimeMethod
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>
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