This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).
Study Type
OBSERVATIONAL
Enrollment
71
Dignity Health, St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Vanderbilt University
Nashville, Tennessee, United States
Occurrence of Postoperative Air Leaks
Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Occurrence of Prolonged Air Leaks
Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Length of Stay (LOS)
Determined as the length of time in days from hospital admission to initial hospital discharge
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Volume of Estimated Intra-operative Blood Loss
Time frame: Blood loss intra-op and up to 5 days post-op
Time to Chest Tube Removal
Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
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Operative Time
Defined as the duration in hours from the first skin incision to the closure of the last incision
Time frame: Day of surgery
Occurrence of Intra-operative Leak Test
This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.
Time frame: During surgery
Number of Subjects With 1 Chest Tube Placed
All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.
Time frame: During surgery