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Repeat Sternotomy for Pediatrics

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ClinicalTrials.gov Identifier: NCT00485745
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta

June 12, 2007
June 13, 2007
December 2, 2014
January 2002
November 2009   (Final data collection date for primary outcome measure)
Retrospective medical record review evaluating preoperative and intraoperative variables associated with repeat sternotomy as risk factors for adverse events. [ Time Frame: Length of stay ]
This study will be a retrospective medical record review evaluating preoperative and intraoperative variables associated with repeat sternotomy as risk factors for adverse events. Short-term outcomes including ventilator time, intensive care unit and hospital length of stay, blood product utilization, and transfusions will be analyzed to determine the effect of adverse events.
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Complete list of historical versions of study NCT00485745 on ClinicalTrials.gov Archive Site
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Repeat Sternotomy for Pediatrics
Repeat Sternotomy for Pediatric Cardiac Surgery: Indications, Risks and Results

Given the relative lack of information regarding the risks associated with repeat sternotomy in the pediatric patient population, a preliminary screen of the Children's Cardiothoracic Surgery Database was performed to determine how many repeat sternotomies have been performed at this institution within the last 4 years. A total of 1281 repeat sternotomies were identified during this time period.

We propose a retrospective review of the indications, potential risk factors, and short-term outcomes for these procedures. These data would allow a multivariable regression analysis to identify risk factors associated with adverse events during repeat sternotomy.

Median sternotomy is the most common approach for cardiac surgery in adults and children. While the initial sternotomy is rarely associated with adverse events, the risks associated with repeated sternotomies for subsequent reoperations may be higher. This increased risk is primarily due to adhesions securing cardiac structures to the sternum, thus placing those structures at risk for injury during sternal re-entry. There have been several large studies examining the frequency and impact of adverse events during repeat sternotomy in adults. Roselli and colleagues from the Cleveland Clinic reviewed 1853 consecutive repeat sternotomies and found a 6.8% incidence of serious adverse events. 1 This study can be contrasted against the report of O'Brien and colleagues which reviewed the results of 546 repeat sternotomies performed over 21 years in Brisbane, Australia with only 9 (1.6%) minor cardiac injuries and no major adverse events. 2

The pediatric cardiac surgical field is somewhat different from the adult realm in that re-operations are more common, either due to planned, staged palliation requiring multiple operations or the expected failure of implanted conduits and valves which subsequently require replacement. However, while the incidence of repeat sternotomy is higher in the pediatric population, the overall number of patients is considerably smaller, so there has been a relative dearth of information in the literature regarding the risks and outcomes associated with repeat sternotomy. The largest series reported was published by Russell and colleagues in 1998 and included only 192 repeat sternotomies performed on 165 patients. 3 The authors reported a 5.2% incidence of cardiac laceration with selective utilization of femoro-femoral bypass to decompress the heart during repeat sternotomy for "higher risk" patients.

Observational
Time Perspective: Retrospective
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Probability Sample
The study population for this retrospective chart review will be all patients, under 21 years of age who have undergone a repeat sternotomy at Children's Healthcare of Atlanta at Egleston between January 1, 2002 and December 31, 2006. A repeat sternotomy is defined as having been performed more than a month after the most recent previous sternotomy.
Congenital Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1281
Same as current
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Repeat sternotomy at Children's Healthcare of Atlanta between 1.1.02 and 12.31.06
  • patient under 21 years of age
  • "repeat" is defined as a sternotomy performed more than 1 month after the most recent previous sternotomy

Exclusion Criteria:

  • Those charts that do not meet inclusion criteria
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00485745
07-023
No
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Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
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Principal Investigator: Paul M Kirshbom, MD Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
November 2014