Back to resultsFast Track Rehabilitation Following Video-assisted Lung Segmentectomy
Primary Purpose
Multiple Pulmonary Nodules
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
VATS
Mini thoracotomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Pulmonary Nodules focused on measuring Lung, Nodule, Rehabilitation, VATS, Thoracotomy
Eligibility Criteria
Inclusion Criteria:
- Patients with undiagnosed multiple pulmonary nodules
Exclusion Criteria:
- Centrally located lesions
- previous thoracotomy
- extensive lung consolidation, and inability to achieve one lung ventilation
Sites / Locations
- Thoracic Surgery Department, Theagenio Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Video-assisted lung segmentectomy
Mini thoracotomy
Arm Description
Patients undergoing VATS segmentectomy
Patients undergoing lung segmentectomy through a mini thoracotomy
Outcomes
Primary Outcome Measures
Duration of hospital stay
Secondary Outcome Measures
postoperative morbidity
Full Information
NCT ID
NCT01397045
First Posted
July 14, 2011
Last Updated
March 26, 2014
Sponsor
Theagenio Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01397045
Brief Title
Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Theagenio Cancer Hospital
4. Oversight
5. Study Description
Brief Summary
Aim of this prospective randomized study is to assess the safety and efficacy of video-assisted lung segmentectomy (Group B) comparing with mini muscle-sparing thoracotomy (group A) during diagnostic process for pulmonary nodules.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Pulmonary Nodules
Keywords
Lung, Nodule, Rehabilitation, VATS, Thoracotomy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video-assisted lung segmentectomy
Arm Type
Active Comparator
Arm Description
Patients undergoing VATS segmentectomy
Arm Title
Mini thoracotomy
Arm Type
Other
Arm Description
Patients undergoing lung segmentectomy through a mini thoracotomy
Intervention Type
Other
Intervention Name(s)
VATS
Intervention Description
Video-assisted lung segmentectomy
Intervention Type
Procedure
Intervention Name(s)
Mini thoracotomy
Intervention Description
Mini muscle sparing thoracotomy for lung segmentectomy
Primary Outcome Measure Information:
Title
Duration of hospital stay
Time Frame
Participants will be followed till home discharge, an average of 2 weeks
Secondary Outcome Measure Information:
Title
postoperative morbidity
Time Frame
Participants will be followed till home discharge, an average of 2 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with undiagnosed multiple pulmonary nodules
Exclusion Criteria:
Centrally located lesions
previous thoracotomy
extensive lung consolidation, and inability to achieve one lung ventilation
Facility Information:
Facility Name
Thoracic Surgery Department, Theagenio Cancer Hospital
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy
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