Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Medical Therapy	Piperacillin/Tazobactam	Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.
Surgical Intervention	Surgical Treatment	Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.
Surgical Intervention	Piperacillin/Tazobactam	Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.

Primary Outcome Measures

Name	Time	Method
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent	1 Year	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Long-term Complications in Medical Therapy Group	1 Year	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.
Readmission Rates	1 Year	Percentage of patients readmitted to the hospital after discharge.

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