Study of Endoscopic Versus Open Harvest of the Radial Artery in Coronary Artery Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT00303706|
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : September 28, 2007
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: Endoscopic Radial Artery Harvest||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial of Endoscopic Versus Conventional Harvesting of the Radial Artery in Coronary Artery Bypass|
|Study Start Date :||April 2005|
|Actual Study Completion Date :||August 2007|
- The primary outcome event will be the rate of forearm wound infection at 6 weeks. [ Time Frame: 6 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303706
|London Health Sciences Centre, University Hospital|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Bob Kiaii, MD, FRCSC||Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital|