Endoscopic Harvesting in Coronary Artery Bypass Grafting.

Sponsor

Dr. Gianluigi Bisleri (Other)

Overall Status

Completed

CT.gov ID

NCT04127461

Collaborator

Medtronic (Industry)

773

Enrollment

Arms

27.9

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Bypass Stenosis Graft Infection	Device: Medtronic endoscope	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

773 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

retrospective data collection

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Sep 3, 2016

Actual Primary Completion Date :

Dec 20, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open vessel harvesting Arm 1 is the conventional procedure	Device: Medtronic endoscope The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.
Experimental: Medtronic endoscope Arm 2 - is the minimally invasive procedure	Device: Medtronic endoscope The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.

Arm

Intervention/Treatment

Active Comparator: Open vessel harvesting

Arm 1 is the conventional procedure

Device: Medtronic endoscope

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

Experimental: Medtronic endoscope

Arm 2 - is the minimally invasive procedure

Device: Medtronic endoscope

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

Outcome Measures

Primary Outcome Measures

cost analysis [6 months]
economic cost of open versus endoscopic vessel harvesting

Secondary Outcome Measures

Length of stay [2 days]
days beyond normal length of stay
infection [6 months]
infection of graft harvesting site

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

undergoing a simultaneous procedure.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dr. Gianluigi Bisleri
Medtronic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Gianluigi Bisleri, Associate Professor, Department of Surgery, Queen's University, Queen's University

ClinicalTrials.gov Identifier:

NCT04127461

Other Study ID Numbers:

SURG-400-17

First Posted:

Oct 15, 2019

Last Update Posted:

Oct 15, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 15, 2019