Endoscopic Harvesting in Coronary Artery Bypass Grafting.

Coronary Bypass Stenosis Clinical Trial

Official title:

Endoscopic Harvesting of the Radial Artery and Saphenous Vein Grafts in Coronary Artery Bypass Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04127461
• Other study ID #: SURG-400-17
• Status: Completed
• Phase: N/A
• Start date: September 3, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2019
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a retrospective data collection looking at patients who received either an endoscopic vessel harvesting procedure versus the conventional open procedure. Besides looking at cost variables in the 2 groups, other outcomes of interest include length of hospital stay, rates of infection, medication use, re-admissions and compilations.

Description:

Since April 2018, the study database has been updated with all patients (currently there are 340 patients per group) and variables - both reflecting effectiveness of the procedure and cost. Preoperative variables being captured include comorbidity factors and variables relating to the Society of Thoracic Surgery (STS) score , which is a pre-procedure assessment of surgical risk.

The postoperative data collection includes a variety of complications and comorbidities the patient could experience during their hospital stay. These variables will provide us with information regarding procedure effectiveness, patient recovery and further costs associated with the procedure. Medications and antibiotics provided during the stay are also being captured. Total hospital costs will include any costs associated with ward stay, separated per level of care: Intensive Care Unit (ICU), Cardiac Surgical Unit (CSU), and regular ward.

The two follow up periods are 30 days and 6 months. Both look at the same effectiveness variables, any emergency room (ER) visits, re-admissions, and their respective reasons. Quality of life will be obtained by looking at the number of complications the patient experienced during these periods. The frequency of home care services provided to each patient, if any, are also being tracked. Cost calculations will be done by obtaining the time, length and number of visits to the ER, re-admissions and clinic visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 773
• Est. completion date: December 31, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

Inclusion Criteria:

• any patient at the KHSC undergoing a CABG procedure requiring a vein graft.

Exclusion Criteria:

• undergoing a simultaneous procedure.

Related Conditions & MeSH terms

• Coronary Bypass Stenosis
• Graft Infection

Intervention

Device:
• Medtronic endoscope
The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Gianluigi Bisleri	Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cost analysis	economic cost of open versus endoscopic vessel harvesting	6 months
Secondary	Length of stay	days beyond normal length of stay	2 days
Secondary	infection	infection of graft harvesting site	6 months