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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01121341 |
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Date of registration:
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07/05/2010 |
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Primary sponsor: |
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Public title:
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ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial
ESOS |
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Scientific title:
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ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery. |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01121341 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Antonio Campanella, MD |
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Address:
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Telephone:
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+39 011 633 55 11 |
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Email:
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antoniocampanella@libero.it |
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Affiliation:
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Name:
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Antonio Campanella, MD |
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Address:
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Telephone:
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+39 011 633 55 11 |
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Email:
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antoniocampanella@libero.it |
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Affiliation:
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Name:
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Antonio Campanella, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy |
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Name:
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Mauro Rinaldi, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Elective planned CABG surgery
- First isolated CABG surgery
Exclusion Criteria:
- Emergency revascularization: patients with hemodynamic instability or requiring
inotropic or intra-aortic balloon support
- Previous cardiac surgery
- Planned concomitant valve surgery
- Very varicous veins
- Previous saphenectomy
- History of deep vein thrombosis
- History of suffered trauma on the lower extremity
- Preoperative legs immobilization
- Previous leg wound complications
- Coexisting illness with life expectancy < five years
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Bypass Grafting Surgery
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Intervention(s)
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Procedure: Vein harvesting
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Primary Outcome(s)
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Morbidity hypothesis
[Time Frame: six weeks]
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Patient satisfaction hypothesis
[Time Frame: six weeks]
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Quality of vein harvesting hypothesis
[Time Frame: six weeks]
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Resource utilization hypothesis
[Time Frame: six weeks]
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Secondary Outcome(s)
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outcome hypothesis
[Time Frame: 18 months]
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Vein-graft patency hypothesis
[Time Frame: six weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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