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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-01

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.

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Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medical Therapy

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.

Group Type ACTIVE_COMPARATOR

Piperacillin/Tazobactam

Intervention Type DRUG

24 hours of IV antibiotic administration

Surgical Intervention

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.

Group Type ACTIVE_COMPARATOR

Piperacillin/Tazobactam

Intervention Type DRUG

24 hours of IV antibiotic administration

Surgical Treatment

Intervention Type PROCEDURE

Appendectomy

Interventions

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Piperacillin/Tazobactam

24 hours of IV antibiotic administration

Intervention Type DRUG

Surgical Treatment

Appendectomy

Intervention Type PROCEDURE

Other Intervention Names

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Appendectomy

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes