Non-operative Management of Early Appendicitis in Children

Non-operative management of appendicitis with antibiotics alone has recently emerged as a
viable treatment alternative to appendectomy. There have been several clinical trials in
adults which conclude that antibiotics alone are a safe initial treatment for appendicitis;
none of these studies included children.

The primary objective of this study is to determine: conversion to surgery (failure of
nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in
children treated with non-operative management. Recurrence is defined as need for
appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to
return to school, costs of care and quality of life measures between the study group and
those that receive standard of care.We hypothesize that non-operative management of early
appendicitis in children with antibiotics alone will be successful in 80% of children at 1
year follow-up.

This is a prospective, non-randomized single-site trial measuring the feasibility of treating
children (7-17 years old) with early appendicitis with antibiotics only (non-operative
management). There will be two cohorts; those who agree to receive non-operative management
(Non-Operative Group) and those that permit us to track their standard treatment course
(Surgery Group).

Inclusion Criteria:

- Age : 7-17 years

- Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, <1.1 cm in
diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT:
hyperemia, fat stranding, <1.1 cm in diameter, no abscess, no fecalith, no phlegmon)

- White blood cell count (WBC) < 15,000

- C reactive protein (CRP) <4 (if obtained)

- Focal abdominal pain
Exclusion Criteria:

- English is not the primary language of either the child or parent/guardian

- Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary
disease, diabetes, obesity (BMI ≥ 95th percentile for age and sex), severe
developmental delay

- Positive urine pregnancy test

- Diffuse peritonitis

- Fecalith

- History of chronic intermittent abdominal pain

- WBC >/= 15

- CRP>/= 4 (if obtained)

- Pain > 36 hours prior to first antibiotic dose or any evidence on imaging studies
concerning for evolving perforated appendicitis including abscess or phlegmon