Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Michigan.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Michigan
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00540189
First received: October 4, 2007
Last updated: June 3, 2008
Last verified: June 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 4, 2007 | ||||
| Last Updated Date | June 3, 2008 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
cost effectiveness [ Time Frame: 3 months post entry into the study ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00540189 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children | ||||
| Official Title ICMJE | Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Perforated Appendicitis | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | November 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:children
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 2 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00540189 | ||||
| Other Study ID Numbers ICMJE | HUM00007791 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steven Bruch, University of Michigan | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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