Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

December 16, 2016 updated by: Steven W. Bruch, University of Michigan
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Mott Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:children

  • Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

  • Age <2 and >18
  • Pregnancy
  • Immunocompromise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Initial appendectomy
children with complicated appendicitis will undergo initial appendectomy
Procedure: Initial appendectomy
Other: Interval appendectomy
children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy
Procedure: Interval appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cost effectiveness
Time Frame: 3 months post entry into the study
3 months post entry into the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Steven W Bruch, MD, MSc, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 4, 2007

First Submitted That Met QC Criteria

October 4, 2007

First Posted (Estimate)

October 5, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00007791

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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