Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Michigan
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- cost effectiveness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 2-17 with a diagnosis of perforated appendicitis
Exclusion Criteria
- •Age <2 and >18
- •Pregnancy
- •Immunocompromise
Arms & Interventions
Initial appendectomy
children with complicated appendicitis will undergo initial appendectomy
Intervention: Initial appendectomy (Procedure)
Interval appendectomy
children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy
Intervention: Interval appendectomy (Procedure)
Outcomes
Primary Outcomes
cost effectiveness
Time Frame: 3 months post entry into the study
Secondary Outcomes
No secondary outcomes reported
Investigators
Steven W. Bruch
Clinical Assoicate Professor
University of Michigan