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Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

This study has been terminated.
(Unable to adequatly recruit)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540189
First Posted: October 5, 2007
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steven W. Bruch, University of Michigan
October 4, 2007
October 5, 2007
December 19, 2016
May 2008
January 2010   (Final data collection date for primary outcome measure)
cost effectiveness [ Time Frame: 3 months post entry into the study ]
Same as current
Complete list of historical versions of study NCT00540189 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Perforated Appendicitis
  • Procedure: Initial appendectomy
  • Procedure: Interval appendectomy
  • Initial appendectomy
    children with complicated appendicitis will undergo initial appendectomy
    Intervention: Procedure: Initial appendectomy
  • Interval appendectomy
    children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy
    Intervention: Procedure: Interval appendectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
January 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:children

  • Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

  • Age <2 and >18
  • Pregnancy
  • Immunocompromise
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00540189
HUM00007791
No
Not Provided
Not Provided
Steven W. Bruch, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Steven W Bruch, MD, MSc University of Michigan
University of Michigan
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP