Collection of 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) in a Korean population.
This clinical trial assessed the use of a powered stapler for transection in VATS lung resection, where there is currently limited published clinical data. The primary study endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure details and perioperative outcomes associated with VATS lung resections were also evaluated.
Study Type
OBSERVATIONAL
Enrollment
105
The study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Korean University Guro Hospital
Seoul, Seoul, South Korea
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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
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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