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Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

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ClinicalTrials.gov Identifier: NCT00540189
Recruitment Status : Terminated (Unable to adequatly recruit)
First Posted : October 5, 2007
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Steven W. Bruch, 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.

Condition or disease Intervention/treatment Phase
Perforated Appendicitis Procedure: Initial appendectomy Procedure: Interval appendectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arm Intervention/treatment
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



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


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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

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

Responsible Party: Steven W. Bruch, Clinical Assoicate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00540189     History of Changes
Other Study ID Numbers: HUM00007791
First Posted: October 5, 2007    Key Record Dates
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