protocol for the 2 × 2 factorial designed randomised NEO trial
BACKGROUND: Coronary artery bypass grafting using the radial artery has, since the 1990s, gone through a revival. Observational studies have indicated better long-term patency when using radial arteries. Therefore, radial artery might be preferred especially in younger patients where long time patency is important. During the last 10 years different endoscopic techniques to harvest the radial artery have evolved. Endoscopic radial artery harvest only requires a small incision near the wrist in contrast to open harvest, which requires an incision from the elbow to the wrist. However, it is unknown whether the endoscopic technique results in fewer complications or a graft patency comparable to open harvest. When the radial artery has been harvested, there are two ways to use the radial artery as a graft. One way is sewing it onto the aorta and another is sewing it onto the mammary artery. It is unknown which technique is the superior revascularisation technique. METHODS/DESIGN: The NEO Trial is a randomised clinical trial with a 2 × 2 factorial design. We plan to randomise 300 participants into four intervention groups: (1) mammario-radial endoscopic group; (2) aorto-radial endoscopic group; (3) mammario-radial open surgery group; and (4) aorto-radial open surgery group.The hand function will be assessed by a questionnaire, a clinical examination, the change in cutaneous sensibility, and the measurement of both sensory and motor nerve conduction velocity at 3 months postoperatively. All the postoperative complications will be registered, and we will evaluate muscular function, scar appearance, vascular supply to the hand, and the graft patency including the patency of the central radial artery anastomosis. A patency evaluation by multi-slice computer tomography will be done at one year postoperatively.We expect the nerve conduction studies and the standardised neurological examinations to be able to discriminate differences in hand function comparing endoscopic to open harvest of the radial artery. The trial also aims to show if there is any patency difference between mammario-radial compared to aorto-radial revascularisation techniques but this objective is exploratory. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01848886.Danish Ethics committee number: H-3-2012-116.Danish Data Protection Agency: 2007-58-0015/jr.n:30-0838.
Trials, 2014, Vol 15, Issue 1, p. 1-18
Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Aorta; Aortography; Clinical Protocols; Coronary Artery Bypass; Denmark; Endoscopy; Female; Graft Occlusion, Vascular; Hand Injuries; Humans; Male; Mammary Arteries; Multidetector Computed Tomography; Pain Measurement; Pain, Postoperative; Predictive Value of Tests; Questionnaires; Radial Artery; Research Design; Risk Factors; Time Factors; Tissue and Organ Harvesting; Treatment Outcome; Vascular Patency