Overview

This trial is active, not recruiting.

Condition appendicitis
Sponsor Katherine Deans
Start date October 2012
End date February 2014
Trial size 102 participants
Trial identifier NCT01718275, IRB12-00406

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients and caregivers who agree to receive non-operative management with antibiotics alone
Patients and caregivers who decide to undergo appendectomy that permit us to track their standard treatment course

Primary Outcomes

Measure
Failure of Non-operative management
time frame: 1 year

Secondary Outcomes

Measure
Adverse Outcomes
time frame: 1 year

Eligibility Criteria

Male or female participants from 7 years up to 17 years old.

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 /= 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

Additional Information

Official title Non-operative Management of Early Appendicitis in Children
Principal investigator Katherine J Deans, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Nationwide Children's Hospital.