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Clinical Trials/NCT04127461
NCT04127461
Completed
Not Applicable

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

Dr. Gianluigi Bisleri0 sites773 target enrollmentSeptember 3, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Bypass Stenosis
Sponsor
Dr. Gianluigi Bisleri
Enrollment
773
Primary Endpoint
cost analysis
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 3, 2016
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Gianluigi Bisleri
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Gianluigi Bisleri

Associate Professor, Department of Surgery, Queen's University

Queen's University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • undergoing a simultaneous procedure.

Outcomes

Primary Outcomes

cost analysis

Time Frame: 6 months

economic cost of open versus endoscopic vessel harvesting

Secondary Outcomes

  • Length of stay(2 days)
  • infection(6 months)

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