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Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Information source: Nationwide Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Appendicitis

Intervention: Antibiotics only (Zosyn then Augmentin) (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Peter Minneci

Official(s) and/or principal investigator(s):
Peter C Minneci, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital


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.

Clinical Details

Official title: Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Success rate of non-operative management

Secondary outcome:

Disability days

Rate of complicated appendicitis


Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.


Inclusion Criteria:

- Age : 7-17 years

- Abdominal pain

- White Blood Cell Count >5 but < 18

- US or CT confirmed early appendicitis plus:

- US:

- CT: 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

Locations and Contacts

Nationwide Children's Hospital, Columbus, Ohio 43205, United States
Additional Information

Related publications:

Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, Deans KJ. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014 Aug;219(2):272-9. doi: 10.1016/j.jamcollsurg.2014.02.031. Epub 2014 Apr 13.

Starting date: July 2014
Last updated: August 14, 2015

Page last updated: August 23, 2015

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