Viewing Study NCT02189668


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Study NCT ID: NCT02189668
Status: TERMINATED
Last Update Posted: 2018-11-27
First Post: 2014-07-03
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Non-operative Management of Pediatric Appendicitis With an Appendicoltih
Sponsor: Peter Minneci
Organization:

Study Overview

Official Title: Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children
Status: TERMINATED
Status Verified Date: 2018-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: High failure rate
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.
Detailed Description: This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: