A randomised study comparing three types of vein harvesting method for coronary artery bypass surgery

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2014
INTERVENTION: Computer block randomisation assigned the patients to undergo an open vein harvesting (control group: n=150), Closed tunnel CO2 endoscopic vein harvesting (n=150) and Open tunnel CO2 endoscopic vein harvesting (n=150). The assignment number will be concealed in a closed envelope separately for each patient by an independent Statistical team member who are not involved in this study or involved to the research group. The envelope will be delivered and opened by the surgical team (as late as possible ), once the patient is anaesthetised for the surgery on the operating room. Control group: Will receive a standard open vein harvesting with a long incision on their donor leg. Group 1 : Closed tunnel : Will receive a endoscopic vein harvesting (Maquet EVH device) of two or three 2‐3 cm cut in their donor leg. Group 2: Open tunnel : Will receive a endoscopic vein harvesting (Sorin EVH device) of two or three 2‐3 cm cut in their donor leg. All the patients in this study will be donoating 3 cm (1cm x3) of vein samples will be collected from each patient during the surgery and will be send to the laboratory for tissue investigations. All the patients will be followed up until their discharge from day 1 of their operation. They will be contact on the telephone at 3 month intervals within the first year, and then at 1,3 and 5 years. CONDITION: Coronary artery bypass surgery ; Surgery PRIMARY OUTCOME: Long saphenous vein integrity, as indicated by the level of histological damage SECONDARY OUTCOME: 1. Post‐surgical clinical outcomes, specifically major adverse cardiac events such as reoccurrence of angina, myocardial infarction, vein graft failure, mortality and wound complications; 2. Patient reported outcomes: generic health related quality of life; 3. Health economic analysis: the costs and effects of the three approaches to vein harvesting INCLUSION CRITERIA: 1. Patients undergoing CABG surgery at the University Hospital of South Manchester 2. Aged 18 or over 3. Written informed consent
Epistemonikos ID: a5cd2e1ff54ddccf149581b9f73215ee17bb8645
First added on: Aug 23, 2024