Status:
TERMINATED
Non-operative Management of Pediatric Appendicitis With an Appendicoltih
Lead Sponsor:
Peter Minneci
Conditions:
Appendicitis
Eligibility:
All Genders
7-17 years
Phase:
NA
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 ima...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02189668
Start Date
July 1 2014
End Date
July 1 2015
Last Update
November 27 2018
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205