Surgical Outcomes in Pediatric Patients With Coarctation and VSD

Between January 1, 2002 and December 31, 2005 Clinical Trial

Official title:

Staged Approach to Coarctation and VSD Can Offer Optimal Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00327795
• Other study ID #: 06-010
• Status: Terminated
• Phase: N/A
• First received: May 18, 2006
• Last updated: March 14, 2012
• Start date: January 2006
• Est. completion date: November 2007

Study information

• Verified date: January 2006
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Recently, a paper was published that compared outcomes of patients requiring repair of aortic coarctation and ventricular septal defect. Some surgeons opt to repair both defects in one surgery while other surgeons do the repair in two separate operations. Recently at Children's Healthcare of Atlanta, we have adopted the practice of correcting both defects during the same operation but through two separate incisions (one on the chest and the other through the ribs on the side. This reduces the amount of time the patient is on the heart-lung bypass machine during surgery. This study is a review of patient charts to compare outcomes of patients who have had surgery to repair their coarctation and VSD during 2002 through 2005.

Description:

This study is a retrospective chart review of patients who carry the diagnosis of aortic coarctation and VSD and have had their surgical repair at Children's Healthcare of Atlanta between the dates of January 1, 2002 and December 31, 2005. The data collected will be surgical data such as type of repair, and the time the patient required cross clamp, circulatory arrest and cardiopulmonary bypass while in the operating room for the repair(s). We would also like to gather post-operative information such as time the patient required ventilation, whether they required a re-operation during the same admission, along with intensive care hours and hospital length of stay.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of coarctation and VSD

• surgical repair at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.

Exclusion Criteria:

• does not have coarctation and VSD

• did not have surgery at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aortic Coarctation
• Between January 1, 2002 and December 31, 2005
• Diagnosis of Coarctation of the Aorta and VSD
• Surgical Repair at CHOA

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States,