Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Study Overview
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Brief Summary
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To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.

Detailed Description
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This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

Official Title
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Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children

Conditions
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Appendicitis

Intervention / Treatment
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* Drug: Antibiotics only (Zosyn then Augmentin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age : 7-17 years Abdominal pain </= 48hours prior to receiving antibiotics White Blood Cell Count >5 but < 18 US or CT confirmed early appendicitis plus: US: </=1.1 cm in diameter, presence of appendicolith CT: </= 1.1cm in diameter, presence of appendicolith Exclusion Criteria: Positive urine pregnancy test Pain > 48 hours prior to first antibiotic dose Diffuse peritonitis History of chronic intermittent abdominal pain White Blood Cell count ≤ 5 or ≥ 18 Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-operative Management<br>Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic | Drug: Antibiotics only (Zosyn then Augmentin)<br>* Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic<br>* Other names: non operative management;|
| No Intervention: Surgery<br>Usual care with urgent appendectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Did Not Have an Appendectomy | Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complicated Appendicitis | Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appendicitis, Non-operative, Children, Appendicolith, fecalith, Pediatrics