Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT00229892
Status:
TERMINATED
Last Update Posted:
2011-11-18
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incisions for Cardiac Surgery
Sponsor:
Children's Healthcare of Atlanta
Organization:
Study Overview
Official Title:
Small Incisions for Cardiac Surgery
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
after 90 charts reviewed, insufficient data to support conclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose is to evaluate the investigators' length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. These data will lead to a new minimally invasive standard of care without a reduction in outcomes.
Detailed Description:
There is a trend in surgery, in general, toward minimal invasion. This includes the transition to laparoscopy/thoracoscopy from open procedures, as well as the reduction in incision size for open procedures. The goal of minimally invasive techniques is to reduce morbidity and length of hospital stay, with a consequent reduction in hospital cost.
There are few cardiac operations that are currently performed with minimally invasive techniques. One of these is the repair of an atrial septal defect, which can be performed though a small skin incision and partial rather than full sternotomy. Another is the ligation of a patent ductus arteriosus, which can be performed through a muscle-sparing thoracotomy rather than a full thoracotomy.
Both of these techniques minimize the scarring and the healing time required for post-operative recovery. We need to be confident that it has not affected our outcomes adversely. We need to evaluate our length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs.
Hopefully, these data will lead to a new minimally invasive standard of care without a reduction in outcomes.
We will review charts before November 1, 2004 at Children's Healthcare of Atlanta.
There are few cardiac operations that are currently performed with minimally invasive techniques. One of these is the repair of an atrial septal defect, which can be performed though a small skin incision and partial rather than full sternotomy. Another is the ligation of a patent ductus arteriosus, which can be performed through a muscle-sparing thoracotomy rather than a full thoracotomy.
Both of these techniques minimize the scarring and the healing time required for post-operative recovery. We need to be confident that it has not affected our outcomes adversely. We need to evaluate our length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs.
Hopefully, these data will lead to a new minimally invasive standard of care without a reduction in outcomes.
We will review charts before November 1, 2004 at Children's Healthcare of Atlanta.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: