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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502695
• Other study ID #: 15-193
• Status: Completed
• Start date: June 2015
• Est. completion date: May 2019

Study information

• Verified date: July 2019
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: May 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• VATS-associated best practices

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmissions rates within 30 days of the patient's surgery date		30 Days
Primary	Incidence of post-operative complications within 30 days of the patient's surgery date		30 Days
Primary	Total inpatient cost		30 Days
Secondary	Difference in readmission rates between the two cohorts	To compare current VATS-associated procedures with a set of best VATS-associated practives implemented across the participating study centers	3 years