Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

Not Applicable

Terminated

• Conditions: Perforated Appendicitis
• Interventions: Procedure: Interval appendectomy; Procedure: Initial appendectomy

• Registration Number: NCT00540189
• Lead Sponsor: University of Michigan

Brief Summary

To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Study First Posted: 2007-10-05
• Study Start: 2008-05
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

children

• Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria

• Age <2 and >18
• Pregnancy
• Immunocompromise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interval appendectomy	Interval appendectomy	children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy
Initial appendectomy	Initial appendectomy	children with complicated appendicitis will undergo initial appendectomy

Primary Outcome Measures

Name	Time	Method
cost effectiveness	3 months post entry into the study

Trial Locations

Locations (1)

Mott Childrens Hospital; 🇺🇸 Ann Arbor, Michigan, United States