Assessment of Video Assisted Thoracoscopic Surgery (VATS) Versus Open Surgery for Patients Undergoing Lobectomy
Terminated
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Procedure: Lobectomy
- Registration Number
- NCT00912366
- Lead Sponsor
- Medtronic - MITG
- Brief Summary
Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
- Subject must be 18 years of age or older.
- Subject must have been clinically diagnosed with stage I to stage IIA non small cell lung cancer measuring and judged to be resectable.
- Subject must be able to tolerate general anesthesia, and have cardiopulmonary reserve to tolerate a lobectomy
Exclusion Criteria
-
Subject is pregnant (documented by pregnancy test) or breastfeeding.
-
Subject has other severe illnesses that would preclude surgery such as
- Unstable angina
- Myocardial Infarction within 3 months
- Coronary Artery Bypass Graft Surgery
-
Subject has other active cancers
-
Subject is unable to comply with any of the following:
- Study requirements
- Give valid informed consent
- Follow-up schedule
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group B Lobectomy Open Surgery Group A Lobectomy VATS
- Primary Outcome Measures
Name Time Method Assess hospital length of stay (LOS). 1 time point (discharge) Pain Scale Evaluation 5 time points out to 6 months
- Secondary Outcome Measures
Name Time Method Assess quality of life. 2 time points out to 6 months Assess peri-operative and post-operative complications. 5 time points out to 6 months.
Trial Locations
- Locations (1)
New York University School of Medicine
🇺🇸New York, New York, United States