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Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University of Michigan.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00540189
First received: October 4, 2007
Last updated: June 3, 2008
Last verified: June 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Michigan:

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

Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: November 2011
  Eligibility

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Bruch, University of Michigan
ClinicalTrials.gov Identifier: NCT00540189     History of Changes
Other Study ID Numbers: HUM00007791 
Study First Received: October 4, 2007
Last Updated: June 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
appendicitis, perforated, children

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

ClinicalTrials.gov processed this record on December 02, 2016