Comparing surgery and symptomatic treatment for appendicitis in children
A Randomized, Controlled Multicenter Feasibility Pilot Trial on Imaging Confirmed Uncomplicated Acute Appendicitis: Appendectomy vs. Symptomatic Treatment in Pediatric Patients (the APPSYPP) Trial Study Protocol
NA · Helsinki University Central Hospital · NCT05289713
This study is testing whether surgery or just treating symptoms works better for kids aged 7-15 with uncomplicated appendicitis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 7 Years to 15 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital (other) |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT05289713 on ClinicalTrials.gov |
What this trial studies
The APPSYPP trial is a multicenter pilot study that compares the effectiveness of appendectomy versus symptomatic treatment in pediatric patients aged 7-15 with uncomplicated acute appendicitis confirmed by imaging. Participants are randomly assigned to either receive an emergency laparoscopic appendectomy or symptomatic treatment, which includes hospitalization for monitoring and supportive care. The primary outcome is treatment success at 30 days, defined by the absence of treatment failure criteria. This study aims to provide insights into the safety and efficacy of non-surgical management for appendicitis in children.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-15 years with imaging-confirmed uncomplicated acute appendicitis and a CRP level of 65 mg/l or lower.
Not a fit: Patients with complicated appendicitis, severe systemic diseases, or those outside the specified age range will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive treatment option for children with uncomplicated acute appendicitis, potentially reducing the need for surgery.
How similar studies have performed: While studies in adults have shown that antibiotic and symptomatic treatments can be effective, this specific comparison in children is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Helsinki
- Helsinki University Central Hospital — Helsinki, Finland (RECRUITING)
Study contacts
- Principal investigator: Janne Suominen, MD, PhD — Helsinki University Central Hospital
- Study coordinator: Janne Suominen, MD, PhD
- Email: janne.suominen@hus.fi
- Phone: +358504272977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Appendicitis, uncomplicated acute appendicitis, symptomatic treatment, spontaneous resolution