Long-term Results Following Endoscopic Vein Harvesting in Coronary Artery Bypass Surgery

NCT01480726 | Completed

• 1 other identifier: N20110023
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Vena saphena magna is still frequently used as graft material in coronary artery bypass grating(CABG, and vein grafts can harvest with either the conventional open technique (Ovh = open vein harvesting), or with less invasive endoscopic techniques (EVH = Endoscopic vein harvesting). The endoscopic techniques have been shown to reduce the incidence of postoperative wound complications while patients are more satisfied with the cosmetic result of the operation on the leg. Non-randomized studies have raised doubts about patency rates of the vein grafts following EVH compared to OVH, while other studies failed to detect any problems in relation to this. There are only very few data on long-term patency rates from randomized studies. The purpose of this study is to investigate clinical outcome and patency rates of the vein grafts following either EVH and OVH in 132 patients who underwent CABG for 4-7 years ago as part of a randomized study investigation wound complications. A cost-effectiveness analysis will also be performed. The hypothesis is: Patency rates following EVH are worse compared to OVH in CABG 4-7 years postoperatively.

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Patency rates of vein grafts

  5-7 years postoperatively

Secondary Outcomes (1)

• recurrence of angina pectoris

  5-7 years postoperatively

Study Arms (2)

Open vein harvest

Conventional open vein harvest from the lower leg

Procedure: Surgery

Endoscopic vein harvest

Endoscopic vein harvest from the calf

Procedure: Surgery

Interventions

Surgery PROCEDURE

Endoscopic vein harvest; Open vein harvest

Eligibility Criteria

• Age: 43 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 132 patients who underwent CABG 4-7 years ago. All patients participated in a randomized study focusing on wound complications from the leg following either open or endoscopic vein harvest.

You may qualify if:

• Patients who participated in the previous randomized study
• Informed consent from the patient

You may not qualify if:

• Survival until date of reexamination
• No informed consent
• CT scan of the heart will not be performed in patients with if: atrial fibrillation,p-creatinin \>120 micromol/l, allergy to contrast, pregnancy, lactating.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

MeSH Terms

Conditions

Angina Pectoris

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan J. Andreasen, MD. PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2011-11

Locations

DK (1)