Incisions for Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Small Incisions for Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00229892
• Other study ID #: 04-120
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 16, 2011
• Start date: February 2005
• Est. completion date: September 2006

Study information

• Verified date: May 2007
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Children who have undergone cardiac surgery at Children's Healthcare of Atlanta

• Surgery before November 1, 2004

Exclusion Criteria;

those who do not fall under the above inclusion criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiac Diseases
• Cardiac Surgery
• Heart Diseases

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States,