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Trial registered on ANZCTR
Registration number
ACTRN12618001842257
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
13/11/2018
Date last updated
15/09/2020
Date data sharing statement initially provided
13/11/2018
Date results information initially provided
13/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Benefits and high patency endoscopic vein harvesting in a flap in patients with coronary heart disease undergoing coronary artery bypass surgery
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Scientific title
Comparison complications and patency bypass grafts after endoscopic vein harvesting in flap versus open vein-graft harvesting in patients undergoing coronary artery bypass surgery.
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Secondary ID [1]
296255
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease
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leg wound complications
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Condition category
Condition code
Surgery
308698
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0
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Surgical techniques
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Cardiovascular
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A randomized study comparing two groups of vein harvesting methods for coronary artery bypass grafting (CABG): endoscopic harvest versus standard open techniques.
Materials: Three hundred patients listed for CABG
Procedures: The endoscopic vein harvesting in flap are performed using an endoscopic video installation Karl Storz. the surgeon performs a cross-section of the skin 3 to 4 cm long at the level of the knee joint. And vein harvest from the leg using retractor (Freiburg model (Karl Storz) with endoscopic optics HOPKINS (Forward-Oblique Telescope 45 ° (Karl Storz). With the help of an electrical dissector, a tunnel is formed along the flap of a vein with a simultaneous harvesting of the flaps itself.
Who: heart surgeon with 10 years experience
Mode of delivery: face to face
Number of times: twenty once/month for 4 months
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Intervention code [1]
312587
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Treatment: Surgery
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Comparator / control treatment
Standard open vein harvesting include longitudinal cut on the leg from the foot to inguinal ligament which is about 70-90 centimeters. Vein harvest with skeletonization under direct vision.
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Control group
Active
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Outcomes
Primary outcome [1]
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The effect vein harvesting technique on postoperative wound-healing complications:
1) using clinical markers of inflammation after removing the sutures (exudates, erythema, bruising and haematoma), identified during the dressing and recorded in the history of the disease;
2) using infection rate (bacteriological examination of wound smears);
3) using frequency of repeated operations (data-linkage to medical records).
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Assessment method [1]
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Timepoint [1]
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During 10 days after operation
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Primary outcome [2]
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The effect of endoscopic vein harvesting in flap on patency. For angiography used angiographic equipment company "Siemens", model "Croscop plus / TOP" (Germany).
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Assessment method [2]
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Timepoint [2]
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First point for angiography is one year after operation, second point after three-five years after operation.
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Secondary outcome [1]
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Secondary hospitalization after discharge due to myocardial infarction. This outcome is assessed by data-linkage to medical records.
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Assessment method [1]
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Timepoint [1]
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Secondary hospitalization after operation due to myocardial infarction in any time after discharge up to 5 years post-operative.
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Eligibility
Key inclusion criteria
coronary artery disease, similar body mass index. Patients with high body mass index have more complications in the lower limbs after surgery therefore body mass index should be the same in both groups
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Minimum age
45
Years
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Maximum age
79
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
heart valve procedures, varicose veins
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
15/11/2018
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Actual
15/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2025
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Actual
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Sample size
Target
300
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Accrual to date
167
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Final
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Recruitment outside Australia
Country [1]
20907
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Russian Federation
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State/province [1]
20907
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Health
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Address [1]
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Tomsk, pr. Kirov, 41
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Country [1]
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Russian Federation
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Primary sponsor type
Government body
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Name
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”
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Address
Tomsk, Cooperative street, 5
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Country
Russian Federation
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
300433
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics committee of Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”
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Ethics committee address [1]
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Tomsk, Cooperative street, 5
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Ethics committee country [1]
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Russian Federation
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Date submitted for ethics approval [1]
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Approval date [1]
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01/01/2013
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Ethics approval number [1]
301625
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Summary
Brief summary
The great saphenous vein still remains one of the most popular additional conduits among others because of the availability and ease of its open harvesting. All described methods of endoscopic venous harvesting are associated with "skeletonization" of an autovenous conduit . The scientific novelty of our work is that we propose to harvest a vein through one mini-incision with the help of Karl Storz endoscopic equipment and the Ligasure electrodissector with surrounding tissues without the use of carbon dioxide. Harvesting vein endoscopically, together with the surrounding tissues, makes it possible to reduce complication in the lower extremities and prolong the patency of the venous conduits by finding itself in the flap.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Vechersky Yuri Yurievich
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Address
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Russia, Tomsk, Kievskaya street 111A.
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”.
Director academician Popov Sergey Valentinovich
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Country
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Russian Federation
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Phone
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+7 (382) 256-12-32
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Zatolokin Vasily Viktorovich
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Address
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Russia, Tomsk, Kievskaya street 111A.
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”.
Name contact person’s work organisation: Zatolokin Vasily Viktorovich
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Country
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Russian Federation
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Phone
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+79138490545
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Zatolokin Vasily Viktorovich
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Address
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Russia,Tomsk, Kievskaya street 111A
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”.
Name contact person’s work organisation: Zatolokin Vasily Viktorovich
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Country
87580
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Russian Federation
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Phone
87580
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+79138490545
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Fax
87580
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all of the individual participant data collected during the trial
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When will data be available (start and end dates)?
Immediately following publication, no end date.
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Available to whom?
anyone who wishes to access it
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Available for what types of analyses?
any purpose
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How or where can data be obtained?
access subject to approvals by Principal Investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
https://www.ncbi.nlm.nih.gov/pubmed/28594806 Publ...
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