Study of Endoscopic Versus Open Harvest of the Radial Artery in Coronary Artery Bypass Surgery

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00303706
First received: March 15, 2006
Last updated: September 27, 2007
Last verified: September 2007

March 15, 2006
September 27, 2007
April 2005
Not Provided
The primary outcome event will be the rate of forearm wound infection at 6 weeks. [ Time Frame: 6 weeks ]
The primary outcome event will be the rate of forearm wound infection at 6 weeks
Complete list of historical versions of study NCT00303706 on ClinicalTrials.gov Archive Site
  • Wound pain [ Time Frame: 6 weeks ]
  • Neurological complications [ Time Frame: 6 weeks ]
  • Patient satisfaction [ Time Frame: 6 weeks ]
  • Length of hospitalization [ Time Frame: will vary with patient lenght of stay ]
  • Histological integrity of the harvested radial artery [ Time Frame: during OR ]
  • Wound pain
  • Neurological complications
  • Patient satisfaction
  • Length of hospitalization
  • Histological integrity of the harvested radial artery.
Not Provided
Not Provided
 
Study of Endoscopic Versus Open Harvest of the Radial Artery in Coronary Artery Bypass Surgery
A Prospective Randomized Trial of Endoscopic Versus Conventional Harvesting of the Radial Artery in Coronary Artery Bypass

The purpose of this study is to compare the safety and effectiveness of minimally invasive endoscopic harvest of the radial artery to the conventional open method of radial artery harvest in coronary artery bypass surgery. The researchers hypothesize that the radial artery can be safely, efficiently, and routinely harvested using a minimally invasive endoscopic technique. Endoscopic minimally invasive harvesting of the radial artery will reduce the postoperative morbidity due to pain, wound infection, and neurological complications and improve cosmetic results.

Many surgical disciplines have been quick to adopt minimally invasive techniques because of decreased complications and shorter recovery times. As we enter the fifth decade of coronary artery bypass grafting surgery more attempts are being made to perform the operation less invasively. Harvesting of the saphenous vein (a large superficial vein in the leg which is routinely used in bypass surgery) using a telescope (camera), has been shown to be superior to harvesting the vein through a large open incision. At our institution, this vein mentioned above, is routinely harvested using less invasive techniques with a camera. This has been shown to result in less infection.

In the early 1990's, the radial artery was reintroduced into bypass surgery to increase the number of available alternative bypass grafts. Long-term results of the radial artery (8-9 years) have shown that 88-91% of the radial arteries harvested remain open thereby allowing the flow of blood. This is significantly better than the 10-year rates of the saphenous vein of 53-67%. Therefore, the radial artery has become more popular as a bypass graft.

Conventionally, the radial artery is harvested by making a long vertical incision extending from the wrist to the elbow. The radial artery is then dissected under direct vision within this large open incision. Complications from the open harvest of the radial artery include infection, neurological complications, possible decrease blood flow to the hand, and poor wound healing or scarring.

Recently, with the development of endoscopic harvesting systems, the radial artery can be harvested using a telescope (camera) and very small incisions. Thus far, to our knowledge there have been no published studies comparing conventional techniques to less invasive endoscopic techniques for harvesting the radial artery. Therefore, we propose a prospective randomized study to determine if the radial artery can be routinely harvested using an endoscopic minimally invasive technique. We wish to compare the conventional open technique to the minimally invasive technique to determine if there are any differences in postoperative complications, length of hospital stay or possible differences in patient satisfaction in cosmetic results (scarring) between the two techniques.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Procedure: Endoscopic Radial Artery Harvest
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
August 2007
Not Provided

Inclusion Criteria:

  • Eligible patients greater than 18 years of age with coronary artery disease requiring elective, urgent, or emergency coronary artery revascularization where the radial artery can be used as a bypass conduit.

Exclusion Criteria:

  • Patient's refusal to have surgery, inability to give informed consent, and contraindication in harvesting the radial artery.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00303706
R-05-053
Not Provided
Not Provided
Lawson Health Research Institute
Johnson & Johnson
Principal Investigator: Bob Kiaii, MD, FRCSC Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
Lawson Health Research Institute
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP