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Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

Primary Purpose

Perforated Appendicitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Initial appendectomy
Interval appendectomy
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perforated Appendicitis focused on measuring appendicitis, perforated, children

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:children

  • Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

  • Age <2 and >18
  • Pregnancy
  • Immunocompromise

Sites / Locations

  • Mott Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Initial appendectomy

Interval appendectomy

Arm Description

children with complicated appendicitis will undergo initial appendectomy

children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy

Outcomes

Primary Outcome Measures

cost effectiveness

Secondary Outcome Measures

Full Information

First Posted
October 4, 2007
Last Updated
December 16, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00540189
Brief Title
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
Official Title
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Unable to adequatly recruit
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforated Appendicitis
Keywords
appendicitis, perforated, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial appendectomy
Arm Type
Other
Arm Description
children with complicated appendicitis will undergo initial appendectomy
Arm Title
Interval appendectomy
Arm Type
Other
Arm Description
children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy
Intervention Type
Procedure
Intervention Name(s)
Initial appendectomy
Intervention Type
Procedure
Intervention Name(s)
Interval appendectomy
Primary Outcome Measure Information:
Title
cost effectiveness
Time Frame
3 months post entry into the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:children Age 2-17 with a diagnosis of perforated appendicitis Exclusion Criteria: Age <2 and >18 Pregnancy Immunocompromise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven W Bruch, MD, MSc
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mott Childrens Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

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