%0 Journal Article
%T Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial
%A Antonio Campanella
%A Laura Bergamasco
%A Luigia Macri
%A Sofia Asioli
%A Roger Devotini
%A Serenella Scipioni
%A Silvana Barbaro
%A Pietro Rispoli
%A Mauro Rinaldi
%J Trials
%D 2011
%I BioMed Central
%R 10.1186/1745-6215-12-243
%X Endoscopic Saphenous harvesting with an Open CO2 System trial includes two parallel vein harvesting arms in coronary artery bypass grafting surgery. It is an interventional, single centre, prospective, randomized, safety/efficacy, cost/effectiveness study, in adult patients with elective planned and first isolated coronary artery disease. A simple size of 100 patients for each arm will be required to achieve 80% statistical power, with a significant level of 0.05, for detecting most of the formulated hypotheses. A six-weeks leg wound complications rate was assumed to be 20% in the conventional arm and less of 4% in the endoscopic arm. Previously quoted studies suggest a first-year vein-graft failure rate of about 20% with an annual occlusion rate of 1% to 2% in the first six years, with practically no difference between the endoscopic and conventional approaches. Similarly, the results on event-free survival rates for the two arms have barely a 2-3% gap. Assuming a 10% drop-out rate and a 5% cross-over rate, the goal is to enrol 230 patients from a single Italian cardiac surgery centre.The goal of this prospective randomized trial is to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.The expected results are of high clinical relevance and will show the safety/efficacy or non-inferiority of one treatment approach in terms of vein harvesting for coronary artery bypass grafting surgery.www.clinicalTrials.gov NCT01121341.Since the introduction of saphenous vein grafting by Ren¨¦ Favaloro in the 1968, coronary artery bypass grafting (CABG) surgery has become one of the most common surgical procedures performed [1]. Although approximately 15% to 20% of vein grafts occlude in the first year with an annual occlusion rate of 1% to 2% in the first six years and 4% to 5% from 6 to 10 years, th
%K coronary disease
%K minimally invasive surgery
%K saphenous vein harvest
%U http://www.trialsjournal.com/content/12/1/243