Endoscopic Harvesting in Coronary Artery Bypass Grafting.

Not Applicable

Completed

• Conditions: Coronary Bypass Stenosis; Graft Infection
• Interventions: Device: Medtronic endoscope

• Registration Number: NCT04127461
• Lead Sponsor: Dr. Gianluigi Bisleri

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.

Study Timeline

• Study Start: 2016-09-03
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-31
• Study First Submitted: 2019-09-24
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-11
• Last Update Submitted: 2019-10-11
• Study First Posted: 2019-10-15
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 773

Inclusion Criteria

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

Exclusion Criteria

• undergoing a simultaneous procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medtronic endoscope	Medtronic endoscope	Arm 2 - is the minimally invasive procedure
Open vessel harvesting	Medtronic endoscope	Arm 1 is the conventional procedure

Primary Outcome Measures

Name	Time	Method
cost analysis	6 months	economic cost of open versus endoscopic vessel harvesting

Secondary Outcome Measures

Name	Time	Method
Length of stay	2 days	days beyond normal length of stay
infection	6 months	infection of graft harvesting site