Endoscopic Harvesting in Coronary Artery Bypass Grafting.

October 11, 2019 updated by: Dr. Gianluigi Bisleri

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

773

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • undergoing a simultaneous procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Open vessel harvesting
Arm 1 is the conventional procedure
Device: Medtronic endoscope
The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.
EXPERIMENTAL: Medtronic endoscope
Arm 2 - is the minimally invasive procedure
Device: Medtronic endoscope
The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost analysis
Time Frame: 6 months
economic cost of open versus endoscopic vessel harvesting
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 2 days
days beyond normal length of stay
2 days
infection
Time Frame: 6 months
infection of graft harvesting site
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Gianluigi Bisleri

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 3, 2016

Primary Completion (ACTUAL)

December 20, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (ACTUAL)

October 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SURG-400-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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