Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer
NCT03997799 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-04-26
Summary
Aim of the study is to compare safety and tolerance of two techniques of Video Assisted Thoracic Surgery (VATS) uniportal lobectomies in the prospective randomized single-institutional trial. One arm is a uniportal lobectomy performed through the transcervical approach with elevation of the sternum, the other arm will utilize a standard uniportal intercostal approache. There will be 10 patients in each group. Patients in clinical stage cI-III (T1-3N0-2M0) Non-Small Cell Lung Cancer (NSCLC). The results will be compared for time of the procedure, number of conversions to multi-portal VATS and/or open thoracotomy, duration and volume of chest drainage, amount of postoperatve pain, time of hospitalization and the number of resected lymph nodes and metastatic nodes. Accrual of patients is planned to complete within 12 months.
Conditions
- Video Assisted Thoracic Surgery (VATS)
- Non-Small Cell Lung Cancer (NSCLC)
Interventions
- PROCEDURE
-
uniportal lobectomy with complete lymphadenectomy
uniportal lobectomy with complete lymphadenectomy
Sponsors & Collaborators
-
Pulmonary Hospital Zakopane
lead OTHER
Principal Investigators
-
Marcin Zielinski, MD PhD · Pulmonary Hospital Zakopane
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-10
- Primary Completion
- 2019-06-10
- Completion
- 2023-07-31
Countries
- Poland
Study Locations
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