A Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)

January 8, 2020 updated by: Scott J. Swanson, MD, Dana-Farber Cancer Institute

A Prospective, Observational, Quality Improvement Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)

This is a research study for participants who have been diagnosed with lung cancer and are receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall objective of this study is to develop a database to collect data on participants who are undergoing VATS lobectomy or segmentectomy for lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This database will be used as for quality improvement purposes. Furthermore, the database will help in collecting data in an organized fashion, which will help the investigators learn more about the details of the workup performed prior to the surgery, during the surgery, peri-operative management and early follow-up. The investigators hope that this database will help to determine a common guideline to perform VATS lobectomy or segmentectomy. By creating a common guideline for future treatment of VATS patients, the investigators predict the efficiency of the process will increase significantly without decreasing, and perhaps even improving, the quality of the procedure.

Study Type

Observational

Enrollment (Actual)

173

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Providence Saint John's Health Center
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown University Medical Center
    • Georgia
      • Austell, Georgia, United States
        • WellStar Medical Group
    • Illinois
      • Evanston, Illinois, United States
        • North Shore University Health System
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University in St. Louis

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants that will have VATS lobectomy and segmentectomy procedures for lung cancer

Description

Inclusion Criteria:

  • Male and female subjects
  • Age ≥ 18 years
  • Underwent a VATS lobectomy or segmentectomy procedure for lung cancer -- Note: patients with other malignancies are eligible if they have a primary cancer of the lung as defined above

Exclusion Criteria:

  • Subjects undergoing thoracotomy lobectomy or segmentectomy for lung cancer
  • Subjects undergoing surgical procedures other than VATS lobectomy or segmentectomy for lung cancer

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1-VATS-associated best practices
  • Data to be collected will include demographic data and information about the pre-operative workup, surgical procedure, postoperative course and early discharge course for these patients.
  • After the last patient completes the 30-day post surgery follow-up, the investigators will determine a set of best practices to implement at each of the sites for the quality improvement initiative. During the assessment period, no patients will be enrolled into the study.
Other: VATS-associated best practices
Cohort 2-VATS-associated best practices
-Once the set of VATS-associated best practices, an additional cohort of approximately 200 patients will be enrolled and followed in a manner identical to the first cohort.
Other: VATS-associated best practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Readmissions rates within 30 days of the patient's surgery date
Time Frame: 30 Days
30 Days
Incidence of post-operative complications within 30 days of the patient's surgery date
Time Frame: 30 Days
30 Days
Total inpatient cost
Time Frame: 30 Days
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in readmission rates between the two cohorts
Time Frame: 3 years
To compare current VATS-associated procedures with a set of best VATS-associated practives implemented across the participating study centers
3 years

Collaborators and Investigators

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

Sponsor

Dana-Farber Cancer Institute

Collaborators

Ethicon Endo-Surgery

Investigators

  • Principal Investigator: Scott J. Swanson, MD, Brigham and Women's Hospital

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)

June 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-193

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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