Endoscopic Harvesting in Coronary Artery Bypass Grafting.

NCT ID: NCT04127461

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 773 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-03
• Study Completion Date: 2018-12-31

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.

Conditions

Coronary Bypass Stenosis; Graft Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Open vessel harvesting

Arm 1 is the conventional procedure

Group Type: ACTIVE_COMPARATOR

Medtronic endoscope

Intervention Type: DEVICE

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

Medtronic endoscope

Arm 2 - is the minimally invasive procedure

Group Type: EXPERIMENTAL

Medtronic endoscope

Intervention Type: DEVICE

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

Interventions

Medtronic endoscope

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• undergoing a simultaneous procedure.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Dr. Gianluigi Bisleri

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gianluigi Bisleri

Associate Professor, Department of Surgery, Queen's University

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

SURG-400-17

Identifier Type: -

Identifier Source: org_study_id