Status:
UNKNOWN
Multi-institutional Trial of Non-operative Management of Appendicitis
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Children's Hospital and Health System Foundation, Wisconsin
Comer Children' Hospital
Conditions:
Appendicitis
Eligibility:
MALE
8-17 years
Brief Summary
A successful non-operative management strategy for early appendicitis will decrease the number of children requiring surgery and may improve the quality of care related to the treatment of appendiciti...
Detailed Description
Several randomized controlled trials comparing appendectomy to antibiotics alone in adults with acute appendicitis have been reported from non-U.S. countries. These studies reveal that non-operative m...
Eligibility Criteria
Inclusion
- English and non-English speaking patients
- Age : 8-17 years
- US or CT confirmed early appendicitis with US showing hyperemia, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon or CT showing hyperemia, fat stranding, ≤ 1.1 cm in diameter, no abscess, no fecalith, no phlegmon
- White Blood Cell count \> 5,000/µL and ≤ 18,000/µL
- Abdominal pain ≤ 48hours prior to receiving antibiotics
Exclusion
- History of chronic intermittent abdominal pain
- Pain \> 48 hours prior to first antibiotic dose
- Diffuse peritonitis
- Positive urine pregnancy test
- White Blood Cell ≤ 5,000/µL or ≥ 18,000/µL
- Presence of a fecalith on imaging
- Evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
- Communication difficulties (e.g. severe developmental delay)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
1076 Patients enrolled
Trial Details
Trial ID
NCT02271932
Start Date
October 1 2014
End Date
November 1 2023
Last Update
February 9 2023
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205