Status:
UNKNOWN
Appendectomy vs. Symptomatic Treatment in Uncomplicated Acute Appendicitis Among Pediatric Patients
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Turku University Hospital
Tampere University Hospital
Conditions:
Appendicitis
Eligibility:
All Genders
7-15 years
Phase:
NA
Brief Summary
The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appe...
Detailed Description
While antibiotic treatment is an effective and safe treatment for most adults and children with imaging-confirmed uncomplicated acute appendicitis, emerging evidence further indicates that antibiotics...
Eligibility Criteria
Inclusion
- age 7-15 years
- clinical diagnosis of uncomplicated acute appendicitis confirmed by US and/or MRI: adequately visualized appendix with a diameter of 6.1-11.0 mm without evidence of perforation, abscess, appendicolith or tumor suspicion
- CRP ≤ 65 mg/l
Exclusion
- inability to give informed consent
- age under 7 or over 15 years
- antibiotic administration within 14 days prior to enrolment
- any previous treatment for acute appendicitis
- severe nausea and/or vomiting preventing oral fluid intake
- systemic disease potentially compromising the safety of symptomatic treatment of acute appendicitis (e.g. type 2 diabetes, malignancy, immune deficiency, or a medical condition requiring immunosuppressant medication)
- diffuse peritonitis or complicated acute appendicitis at imaging (perforation, abscess, appendicolith or tumor suspicion)
- inadequately visualized appendix
- age and sex adjusted BMI over 27 kg/m2 and no MRI performed
- CRP \> 65 mg/l.
Key Trial Info
Start Date :
March 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05289713
Start Date
March 10 2023
End Date
December 1 2025
Last Update
September 26 2023
Active Locations (1)
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1
Helsinki University Central Hospital
Helsinki, Finland