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

Completed

• Conditions: Lung Cancer
• Interventions: Other: VATS-associated best practices

• Registration Number: NCT02502695
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Primary Completion: 2017-12
• Study Completion: 2019-05
• Status Verified: 2019-07
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2-VATS-associated best practices	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.
Cohort 1-VATS-associated best practices	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.

Primary Outcome Measures

Name	Time	Method
Total inpatient cost	30 Days
Readmissions rates within 30 days of the patient's surgery date	30 Days
Incidence of post-operative complications within 30 days of the patient's surgery date	30 Days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Providence Saint John's Health Center; 🇺🇸 Santa Monica, California, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

WellStar Medical Group; 🇺🇸 Austell, Georgia, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

North Shore University Health System; 🇺🇸 Evanston, Illinois, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States