Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-07-31

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.

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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.

Conditions

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Appendicitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-operative Management

Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic

Group Type EXPERIMENTAL

Antibiotics only (Zosyn then Augmentin)

Intervention Type DRUG

Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic

Surgery

Usual care with urgent appendectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antibiotics only (Zosyn then Augmentin)

Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic

Intervention Type DRUG

Other Intervention Names

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non operative management

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No