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ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial (ESOS)

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ClinicalTrials.gov Identifier: NCT01121341
Recruitment Status : Unknown
Verified April 2010 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was:  Recruiting
First Posted : May 12, 2010
Last Update Posted : May 20, 2010
Sponsor:
Collaborator:
LivaNova
Information provided by:
Azienda Ospedaliera San Giovanni Battista

Tracking Information
First Submitted Date  ICMJE May 7, 2010
First Posted Date  ICMJE May 12, 2010
Last Update Posted Date May 20, 2010
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
  • Morbidity hypothesis [ Time Frame: six weeks ]
    When compared to Conventional vein-graft harvesting (CVH) in CABG surgery · Does Endoscopic vein-graft open CO2 system harvesting (EVOH) reduce postoperative wound complications (composite endpoint of all complications or individual complications) assessed with ASEPSIS score?
  • Patient satisfaction hypothesis [ Time Frame: six weeks ]
    · Does EVOH improve patient satisfaction, postoperative leg pain and quality of life assessed with VAS score and EUROQol-5D?
    • To compare health-related quality of life for the two treatment arms (EVOH/CVH) by intention-to-treat
    • To identify factors in addition to treatment assignment that are associated with variations in quality of life outcomes
  • Resource utilization hypothesis [ Time Frame: six weeks ]
    When compared to Conventional vein-graft harvesting (CVH) in CABG surgery · Does EVOH affect resource utilization?
    • Harvesting time related to the length of vein segments
    • Harvesting closure time
    • CABG time
    • Mobility time
    • Hospital length of stay
    • Re-exploration for bleeding due to vein-graft bleed
    • Readmission for leg wound complications
    • Need for outpatient wound management resources
    • To compare total medical costs for the two treatment arms (EVOH/CVH) by intention-to-treat
  • Quality of vein harvesting hypothesis [ Time Frame: six weeks ]
    When compared to Conventional vein-graft harvesting (CVH) in CABG surgery
    • Do EVOH compromises the quality of venous conduit harvested?
      • Number of harvested veins requiring repair
      • Number of repairs to each vein
      • Re-exploration for bleeding due to vein-graft bleed
      • Histological integrity
    • Specific secondary subanalysis adjusted for:
      • Preparation solution of the vein conduit
        • 20 ml autologous blood
        • 0,5 ml heparin (5000UI/ml) = 2500 UI
        • 2 ml papavarine (30mg/ml) = 60 mg
      • Uncontrolled distension pressure/ no touch technique harvesting
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
  • Vein-graft patency hypothesis [ Time Frame: six weeks ]
    Does EVH Open-CO2 system influence and improve vein-graft patency?
    • Assessment of systemic carbon dioxide absorption with respiratory and hemodynamic parameters
    • Assessment of vein-graft patency with:
      • vein conduit quality [diameter/well thickness]
      • vein segments above/below the knee
      • target coronary artery grafted territory
      • target coronary artery diameter
      • target coronary artery stenosis
      • target coronary artery severity disease
      • ascending aorta disease
      • composite /uncomposite graft
      • left ventricular function
  • outcome hypothesis [ Time Frame: 18 months ]
    § Detection of long-term outcomes:
    • MACE (major adverse cardiac events): death; myocardial infarction; revascularization (PCI or CABG) for ischemia or angina recurrence
    • MACE related to vein-graft failure
    • GF (vein-graft failure): at least 75% of stenosis;
    • GO (vein-graft occlusion) at angiographic study
    • to identify factors in addition to treatment assignment that are associated with variations in long-term outcomes and graft patency
    • baseline demographic characteristics and medications used of two treatment arms (EVOH/CVH)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial
Official Title  ICMJE ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery.
Brief Summary The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic open CO2 harvesting system versus conventional vein harvesting.
Detailed Description The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Bypass Grafting Surgery
Intervention  ICMJE Procedure: Vein harvesting
Endoscopic versus conventional vein harvesting
Study Arms  ICMJE
  • Experimental: EVOH
    Procedure: Endoscopic vein with an open CO2 system harvesting
    Intervention: Procedure: Vein harvesting
  • Active Comparator: OVH
    Procedure: Conventional vein harvesting
    Intervention: Procedure: Vein harvesting
Publications * Campanella A, Bergamasco L, Macri L, Asioli S, Devotini R, Scipioni S, Barbaro S, Rispoli P, Rinaldi M. Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial. Trials. 2011 Nov 18;12:243. doi: 10.1186/1745-6215-12-243.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 10, 2010)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01121341
Other Study ID Numbers  ICMJE CEI/7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Silvana Barbaro and Serenella Scipioni, Azienda Ospedaliera San Giovanni Battista
Study Sponsor  ICMJE Azienda Ospedaliera San Giovanni Battista
Collaborators  ICMJE LivaNova
Investigators  ICMJE
Study Chair: Antonio Campanella, MD Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
Principal Investigator: Mauro Rinaldi, MD, PhD Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
PRS Account Azienda Ospedaliera San Giovanni Battista
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP