Repeat Sternotomy for Pediatrics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Children's Healthcare of Atlanta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00485745
First received: June 12, 2007
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Repeat Sternotomy for Pediatric Cardiac Surgery: Indications, Risks and Results

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Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 1281
Study Start Date: January 2002
Estimated Study Completion Date: April 2012
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  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: NCT00485745

Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Paul M Kirshbom, MD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00485745     History of Changes
Other Study ID Numbers: 07-023
Study First Received: June 12, 2007
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
surgery
repeat sternotomy
pediatrics

ClinicalTrials.gov processed this record on October 30, 2014