NCT01121341

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

May 20, 2010

Status Verified

April 1, 2010

Enrollment Period

1.1 years

First QC Date

May 7, 2010

Last Update Submit

May 19, 2010

Conditions

Coronary Artery Bypass Grafting Surgery

Keywords

Endoscopic vein harvestingSaphenous veinConventional vein harvesting

Outcome Measures

Primary Outcomes (4)

  • Morbidity hypothesis

    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?

    six weeks

  • Patient satisfaction hypothesis

    · 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

    six weeks

  • Resource utilization hypothesis

    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

    six weeks

  • Quality of vein harvesting hypothesis

    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

    six weeks

Secondary Outcomes (2)

  • Vein-graft patency hypothesis

    six weeks

  • outcome hypothesis

    18 months

Study Arms (2)

EVOH

EXPERIMENTAL

Procedure: Endoscopic vein with an open CO2 system harvesting

Procedure: Vein harvesting

OVH

ACTIVE COMPARATOR

Procedure: Conventional vein harvesting

Procedure: Vein harvesting

Interventions

Vein harvestingPROCEDURE

Endoscopic versus conventional vein harvesting

EVOHOVH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective planned CABG surgery
  • First isolated CABG surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino

Turin, Piedmont, 10126, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22098690DERIVED

Study Officials

  • Antonio Campanella, MD

    Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy

    STUDY CHAIR

  • Mauro Rinaldi, MD, PhD

    Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Campanella, MD

CONTACT

+39 011 633 55 11antoniocampanella@libero.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2010

First Posted

May 12, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Last Updated

May 20, 2010

Record last verified: 2010-04

Locations

IT(1)