Phase 4
N=39
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Appendicitis
Bottom Line
View on ClinicalTrials.gov: NCT02991937 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent — 91.3; 90.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Piperacillin/Tazobactam (Drug); Surgical Treatment (Procedure)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent |
91.3; 90.2 | — |
| SECONDARY Readmission Rates |
25; 0 | — |
| SECONDARY Incidence of Long-term Complications in Medical Therapy Group |
30 | — |
Summary
Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.
Eligibility Criteria
Inclusion Criteria
- first episode of appendicitis
- Pain < 48 hours
- White blood cell count < 18,000
- temperature < 103º F
- radiographic evidence of acute appendicitis on ultrasound or CT without evidence of perforation
- appendiceal diameter < 11 mm
- ability to take oral antibiotics
Exclusion Criteria
- Prior antibiotic treatment for appendicitis
- presence of medical condition prohibiting surgical therapy
- radiographic or clinical evidence of abscess or perforation
- appendiceal mass, positive pregnancy test
- other diagnosis equally as likely as appendicitis
- pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or appendiceal diameter ≥ 11 mm
- inability to take oral antibiotics.
Data sourced from ClinicalTrials.gov (NCT02991937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.