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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02502695
Collaborator
Ethicon Endo-Surgery (Industry)
173
6
47
28.8
0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: VATS-associated best practices

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 Design

Study Type:
Observational
Actual Enrollment :
173 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Observational, Quality Improvement Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Readmissions rates within 30 days of the patient's surgery date [30 Days]

  2. Incidence of post-operative complications within 30 days of the patient's surgery date [30 Days]

  3. Total inpatient cost [30 Days]

Secondary Outcome Measures

  1. Difference in readmission rates between the two cohorts [3 years]

    To compare current VATS-associated procedures with a set of best VATS-associated practives implemented across the participating study centers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Providence Saint John's Health Center Santa Monica California United States 90404
2 Georgetown University Medical Center Washington District of Columbia United States
3 WellStar Medical Group Austell Georgia United States
4 North Shore University Health System Evanston Illinois United States
5 Brigham and Women's Hospital Boston Massachusetts United States 02115
6 Washington University in St. Louis Saint Louis Missouri United States

Sponsors and Collaborators

  • Dana-Farber Cancer Institute
  • Ethicon Endo-Surgery

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Scott J. Swanson, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02502695
Other Study ID Numbers:
  • 15-193
First Posted:
Jul 20, 2015
Last Update Posted:
Jan 13, 2020
Last Verified:
Jul 1, 2019
Keywords provided by Scott J. Swanson, MD, Principal Investigator, Dana-Farber Cancer Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2020