Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2 × 2 factorial designed randomised NEO trial
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery : protocol for the 2 × 2 factorial designed randomised NEO trial . / Carranza, Christian L; Ballegaard, Martin; Werner, Mads U; Hasbak, Philip; Kjær, Andreas; Kofoed, Klaus F; Lindschou, Jane; Jakobsen, Janus Christian; Gluud, Christian; Olsen, Peter Skov; Steinbrüchel, Daniel A.
In: Trials, Vol. 15, 135, 2014, p. 1-18.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery
T2 - protocol for the 2 × 2 factorial designed randomised NEO trial
AU - Carranza, Christian L
AU - Ballegaard, Martin
AU - Werner, Mads U
AU - Hasbak, Philip
AU - Kjær, Andreas
AU - Kofoed, Klaus F
AU - Lindschou, Jane
AU - Jakobsen, Janus Christian
AU - Gluud, Christian
AU - Olsen, Peter Skov
AU - Steinbrüchel, Daniel A
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - Aorta
KW - Aortography
KW - Clinical Protocols
KW - Coronary Artery Bypass
KW - Denmark
KW - Endoscopy
KW - Female
KW - Graft Occlusion, Vascular
KW - Hand Injuries
KW - Humans
KW - Male
KW - Mammary Arteries
KW - Multidetector Computed Tomography
KW - Pain Measurement
KW - Pain, Postoperative
KW - Predictive Value of Tests
KW - Questionnaires
KW - Radial Artery
KW - Research Design
KW - Risk Factors
KW - Time Factors
KW - Tissue and Organ Harvesting
KW - Treatment Outcome
KW - Vascular Patency
U2 - 10.1186/1745-6215-15-135
DO - 10.1186/1745-6215-15-135
M3 - Journal article
C2 - 24754891
VL - 15
SP - 1
EP - 18
JO - Trials
JF - Trials
SN - 1745-6215
M1 - 135
ER -
ID: 138429222