Non-operative Management of Early Appendicitis in Children
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|ClinicalTrials.gov Identifier: NCT01718275|
Recruitment Status : Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : March 17, 2020
|Condition or disease|
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).
|Study Type :||Observational|
|Actual Enrollment :||102 participants|
|Official Title:||Non-operative Management of Early Appendicitis in Children|
|Actual Study Start Date :||October 2012|
|Actual Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2024|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718275
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Katherine J Deans, MD||Nationwide Children's Hospital|