Compare Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting

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.

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Key information

Conditions

Autovenous Conduit for Coronary Artery Bypass Grafting

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open vein harvesting

Procedure

Open vein harvesting was performed as a continuous incision under vision control. The GSV was identified two fingers proximal to the medial malleolus according to the standard practice. The vein was harvested using Metzenbaum scissors, and a continuous incision was made along the route of the vein. Care was taken not to traumatize the nerve, vein or its branches. Vein branches were ligated with titanium clips. The wound was closed in layers with continuous 2-0 Polysorb sutures and 3-0 skin sutures.

Endoscopic vein harvesting

Procedure

Endoscopic vein harvesting was performed through minimal incisions with use of Vasoview 6 system (Maquet Medical Systems, Wayne, NJ, USA.) The vein was identified through a 3 cm incision below the knee. The incision site was sealed using a balloon port to create a tunnel inside the leg. A second unit with cautery was inserted via the port to cut and seal the tributary branches. A 1 cm skin incision was made near the groin to ligate the distal end of the GSV and remove the vein, which was checked for leakage. The wound was closed with 3-0 skin sutures

Primary outcomes

postoperative wound complications

Time frame: during 30 day after operation

all cases postoperative wound complications

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: May 18, 2015
Registry last updated: May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.