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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
24 hours of IV antibiotic administration
Appendectomy
New York University
New York, New York, United States
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent
Brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of health-related quality of life (HRQOL) in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. PedsQL consists of 23 items scored on a 5-point Likert scale (0=never to 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, and 4=0). The total score range is 0-100; the higher the score, the better the HRQOL.
Time frame: 1 Year
Readmission Rates
Percentage of patients readmitted to the hospital after discharge.
Time frame: 1 Year
Incidence of Long-term Complications in Medical Therapy Group
Incidence of long-term complications will be reported as number of cases where appendicitis reoccurred resulting in appendectomies in participants of the medical therapy arm. This data will be obtained from medical record review.
Time frame: 1 Year
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