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

NCT02446522 | Completed Phase 4

• 1 other identifier: EVH vs OVH
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autovenous Conduit for Coronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (1)

• postoperative wound complications

  all cases postoperative wound complications

  during 30 day after operation

Study Arms (2)

Open vein harvesting

ACTIVE COMPARATOR

Patients with IHD, who were underwent open vein harvest method (OVH)

Procedure: Open vein harvesting

Endoscopic vein harvesting

ACTIVE COMPARATOR

Patients with IHD, who were underwent edoscopic vein harvestingopen vein harvest method (EVH).

Procedure: Endoscopic vein harvesting

Interventions

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.

Open vein harvesting

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

Endoscopic vein harvesting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 18, 2015
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 18, 2015

Record last verified: 2015-05