Endoscopic Harvesting in Coronary Artery Bypass Grafting.

Dr. Gianluigi Bisleri

Status: Completed

Conditions: Graft Infection; Coronary Bypass Stenosis

Treatments: Device: Medtronic endoscope

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04127461

SURG-400-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 773 patients

Sex: All

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• undergoing a simultaneous procedure.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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773 participants in 2 patient groups

Open vessel harvesting

Active Comparator group

Description:

Arm 1 is the conventional procedure

Treatment:

Device: Medtronic endoscope

Medtronic endoscope

Experimental group

Description:

Arm 2 - is the minimally invasive procedure

Treatment:

Device: Medtronic endoscope