Clinical trial NCT01718275: Non-operative Management of Early Appendicitis in Children
Official title: Non-operative Management of Early Appendicitis in Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Appendicitis
Keywords: Appendicitis
Pediatrics
Children
Non-operative
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 102
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children treated a tertiary care Children's Hospital

Brief summary: The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. 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.

Detailed description: 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).

Eligibility criteria: 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 \</= 36 hours prior to receiving antibiotics

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

Primary outcomes:
measure: Failure of Non-operative management
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Peter C Minneci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. doi: 10.1001/jamasurg.2015.4534.
citation: 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.