Trial Review

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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 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
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.
Secondary ID [1] 296255 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 309921 0
leg wound complications 309922 0
Condition category
Condition code
Surgery 308698 308698 0 0
Surgical techniques
Cardiovascular 308905 308905 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 312587 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 307715 0
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).
Timepoint [1] 307715 0
During 10 days after operation
Primary outcome [2] 307716 0
The effect of endoscopic vein harvesting in flap on patency. For angiography used angiographic equipment company "Siemens", model "Croscop plus / TOP" (Germany).
Timepoint [2] 307716 0
First point for angiography is one year after operation, second point after three-five years after operation.
Secondary outcome [1] 353189 0
Secondary hospitalization after discharge due to myocardial infarction. This outcome is assessed by data-linkage to medical records.
Timepoint [1] 353189 0
Secondary hospitalization after operation due to myocardial infarction in any time after discharge up to 5 years post-operative.

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
Minimum age
45 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
heart valve procedures, varicose veins

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2018
Actual
15/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
300
Accrual to date
167
Final
Recruitment outside Australia
Country [1] 20907 0
Russian Federation
State/province [1] 20907 0

Funding & Sponsors
Funding source category [1] 300851 0
Government body
Name [1] 300851 0
Department of Health
Country [1] 300851 0
Russian Federation
Primary sponsor type
Government body
Name
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”
Address
Tomsk, Cooperative street, 5
Country
Russian Federation
Secondary sponsor category [1] 300433 0
None
Name [1] 300433 0
Address [1] 300433 0
Country [1] 300433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301625 0
Ethics committee of Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”
Ethics committee address [1] 301625 0
Ethics committee country [1] 301625 0
Russian Federation
Date submitted for ethics approval [1] 301625 0
Approval date [1] 301625 0
01/01/2013
Ethics approval number [1] 301625 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87578 0
Prof Vechersky Yuri Yurievich
Address 87578 0
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
Country 87578 0
Russian Federation
Phone 87578 0
+7 (382) 256-12-32
Fax 87578 0
Email 87578 0
cardio@cardio-tomsk.ru
Contact person for public queries
Name 87579 0
Zatolokin Vasily Viktorovich
Address 87579 0
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
Country 87579 0
Russian Federation
Phone 87579 0
+79138490545
Fax 87579 0
Email 87579 0
zatolokin@cardio-tomsk.ru
Contact person for scientific queries
Name 87580 0
Zatolokin Vasily Viktorovich
Address 87580 0
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
Country 87580 0
Russian Federation
Phone 87580 0
+79138490545
Fax 87580 0
Email 87580 0
zatolokin@cardio-tomsk.ru

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.