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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
  Purpose
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.

Condition Intervention
Perforated Appendicitis Procedure: Initial appendectomy Procedure: Interval appendectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

Resource links provided by NLM:


Further study details as provided by Steven W. Bruch, University of Michigan:

Primary Outcome Measures:
  • cost effectiveness [ Time Frame: 3 months post entry into the study ]

Enrollment: 23
Study Start Date: May 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Initial appendectomy
children with complicated appendicitis will undergo initial appendectomy
Procedure: Initial appendectomy
Interval appendectomy
children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy
Procedure: Interval appendectomy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:children

  • Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

  • Age <2 and >18
  • Pregnancy
  • Immunocompromise
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540189


Locations
United States, Michigan
Mott Childrens Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Steven W Bruch, MD, MSc University of Michigan
  More Information

Responsible Party: Steven W. Bruch, Clinical Assoicate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00540189     History of Changes
Other Study ID Numbers: HUM00007791
First Submitted: October 4, 2007
First Posted: October 5, 2007
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by Steven W. Bruch, University of Michigan:
appendicitis, perforated, children

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases