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OpenTrials
Completed

NCT Number: NCT04127461

Endoscopic Harvesting in Coronary Artery Bypass Grafting.

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.

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Key information

Conditions

Coronary Bypass Stenosis Graft Infection

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • undergoing a simultaneous procedure.

Treatment and study plan

Medtronic endoscope

Device

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

Primary outcomes

  1. cost analysis

    Time frame: 6 months

    economic cost of open versus endoscopic vessel harvesting

Secondary outcomes

  1. Length of stay

    Time frame: 2 days

    days beyond normal length of stay

  2. infection

    Time frame: 6 months

    infection of graft harvesting site

Sponsors and collaborators

Lead sponsor

Dr. Gianluigi Bisleri

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2019
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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