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Clinical Trials/NCT02446522
NCT02446522CompletedPhase 4

Comparative Results of Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting: a Prospective Randomized Parallel-group Trial.

Meshalkin Research Institute of Pathology of Circulation0 sites228 target enrollmentStarted: January 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
228
Primary Endpoint
postoperative wound complications

Study Overview

Brief Summary

There is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

Detailed Description

The great saphenous vein (GSV) remains one of the most commonly used conduits due to its ease of harvest, availability and versatility [1] Traditional harvesting of GSV is open vein harvesting, which involves an extended leg incision. This technique is associated with a significant morbidity and wound complications occur in 2-24% of cases.

Minimally invasive techniques endoscopic vein harvesting (EVH), have therefore been developed to reduce post-CABG leg wound complications. Last time the endoscopic vein harvesting is the method of choice in many centers as it allowed reduction of post-surgical complications as compared to the open method. Although long-term graft patency following EVH has been questioned cohort studies have reported that the technique is safe and effective.

The possibility to use lymphoscintigraphy for evaluation of lower limb lymphatic system after vein harvesting for the coronary artery bypass surgeries was reported before. Nevertheless, the state of the lymphatic system after vein harvesting remains to be poorly studied.

Currently, there is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • subjects with multivascular lesion of the coronary artery to whom coronary artery bypass surgery was indicated.

Exclusion Criteria

  • urgent coronary artery bypass surgery with unstable haemodynamics;
  • previous coronary artery bypass surgery;
  • chronic venous insufficiency С4-С6 under СЕAR classification;
  • previous limb surgeries.

Outcomes

Primary Outcomes

postoperative wound complications

Time Frame: during 30 day after operation

all cases postoperative wound complications

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Meshalkin Research Institute of Pathology of Circulation
Sponsor Class
Network
Responsible Party
Sponsor

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