Clinical Trial: Non-operative Management of Early Appendicitis in Children

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Non-operative Management of Early Appendicitis in Children

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 Summary:

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).


Sponsor: Katherine Deans

Current Primary Outcome: Failure of Non-operative management [ Time Frame: 1 year ]

The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse Outcomes [ Time Frame: 1 year ]

The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.


Original Secondary Outcome: Same as current

Information By: Nationwide Children's Hospital

Dates:
Date Received: October 29, 2012
Date Started: October 2012
Date Completion: February 2024
Last Updated: August 18, 2016
Last Verified: August 2016