Non-operative Management of Pediatric Appendicitis With an Appendicoltih

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.

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.

Criteria:

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

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

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