A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Sponsor
- Ethicon Endo-Surgery
- Enrollment
- 71
- Locations
- 4
- Primary Endpoint
- Occurrence of Prolonged Air Leaks
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Suspected or confirmed NSCLC (up to and including Stage II)
- •Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
- •Performance status 0-1 (Eastern Cooperative Oncology Group classification)
- •ASA score \< 3
- •No prior history of VATS or open lung surgery
- •Willing to give consent and comply with study-related evaluation and treatment schedule
Exclusion Criteria
- •Active bacterial infection or fungal infection;
- •Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
- •Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
- •Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed)
- •Pregnancy
- •Physical or psychological condition which would impair study participation;
- •The patient is judged unsuitable for study participation by the Investigator for any other reason; or
- •Unable or unwilling to attend follow-up visits and examinations
Outcomes
Primary Outcomes
Occurrence of Prolonged Air Leaks
Time Frame: Post-operative period through hospital discharge and follow-up at Day 30
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).
Occurrence of Postoperative Air Leaks
Time Frame: Post-operative period through hospital discharge and follow-up at Day 30
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).
Secondary Outcomes
- Occurrence of Intra-operative Leak Test(During surgery)
- Time to Chest Tube Removal(Post-operative period through hospital discharge and follow-up at Day 30)
- Operative Time(Day of surgery)
- Length of Stay (LOS)(Post-operative period through hospital discharge and follow-up at Day 30)
- Volume of Estimated Intra-operative Blood Loss(Blood loss intra-op and up to 5 days post-op)
- Number of Subjects With 1 Chest Tube Placed(During surgery)