Re-operative Surgery in Children:A Technique for Sternal Re-Entry
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|ClinicalTrials.gov Identifier: NCT00328146|
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment|
|Congenital Disorders||Other: Observation of sternal reentry|
Background Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.
Methods This will be primarily a technique paper. The only clinical data points I am interested in are how many re-operative sternotomies we performed and on how many patients. I will also need to confirm that we did not have any complications due to cardiac injury while opening the sternum. I estimate about 450 patients.
Primary Aim: Present an effective technique for sternal re-entry in children
Secondary Aim: Present a zero incidence of complicated sternal re-entry over the past 5 years (February 1, 2001 through February 28, 2006) at Children's Healthcare of Atlanta, Egleston Hospital.
Inclusion / Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision
|Study Type :||Observational|
|Actual Enrollment :||802 participants|
|Official Title:||Re-operative Surgery in Children: A Technique for Sternal Re-Entry|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Observation of Sternal Re-entry
Other: Observation of sternal reentry
Observation of sternal reentry
- Present an effective techniqe for sternal re-entry in children.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328146
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Brian E Kogon, MD||Children's Healthcare of Atlanta|