MedPath

Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Not Applicable
Terminated
Conditions
Appendicitis
Interventions
Drug: Antibiotics only (Zosyn then Augmentin)
Registration Number
NCT02189668
Lead Sponsor
Peter Minneci
Brief Summary

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

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
14
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Non-operative ManagementAntibiotics only (Zosyn then Augmentin)Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic
Primary Outcome Measures
NameTimeMethod
Number of Participants That Did Not Have an Appendectomy1 year

Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Complicated Appendicitis1 year

Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.

Trial Locations

Locations (1)

Nationwide Children's Hospital

🇺🇸

Columbus, Ohio, United States

© Copyright 2025. All Rights Reserved by MedPath