Non-operative Management of Early Appendicitis in Children
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Non-operative Management of Early Appendicitis in Children|
- Failure of Non-operative management [ Time Frame: 1 year ] [ Designated as safety issue: No ]The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.
- Adverse Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||February 2024|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718275
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Katherine J Deans, MD||Nationwide Children's Hospital|