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Endoscopic Harvesting in Coronary Artery Bypass Grafting.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04127461
Enrollment
773
Registered
2019-10-15
Start date
2016-09-03
Completion date
2018-12-31
Last updated
2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Bypass Stenosis, Graft Infection

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.

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.

Interventions

DEVICEMedtronic endoscope

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

Sponsors

Medtronic
CollaboratorINDUSTRY
Dr. Gianluigi Bisleri
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Masking description

retrospective data collection

Eligibility

Sex/Gender
ALL
Age
19 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* undergoing a simultaneous procedure.

Design outcomes

Primary

MeasureTime frameDescription
cost analysis6 monthseconomic cost of open versus endoscopic vessel harvesting

Secondary

MeasureTime frameDescription
Length of stay2 daysdays beyond normal length of stay
infection6 monthsinfection of graft harvesting site

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026