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

Study Overview
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Brief Summary
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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.

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

Conditions
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Appendicitis

Intervention / Treatment
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* Drug: Piperacillin/Tazobactam
* Procedure: Surgical Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medical Therapy<br>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. | Drug: Piperacillin/Tazobactam<br>* 24 hours of IV antibiotic administration<br>|
| Active Comparator: Surgical Intervention<br>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. | Drug: Piperacillin/Tazobactam<br>* 24 hours of IV antibiotic administration<br>Procedure: Surgical Treatment<br>* Appendectomy<br>* Other names: Appendectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission Rates | Percentage of patients readmitted to the hospital after discharge. | 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. | 1 Year |