Needlescopic-assisted Uniportal vs Uniportal VATS (UNeed)
Primary Purpose
Lung Cancer, Lung Cancer Metastatic, Bullous Disease Lung
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Thoracoscopic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Thoracoscopy, VATS, Needlescopy, Uniportal
Eligibility Criteria
Inclusion Criteria:
Lung or mediastinal disease requiring thoracoscopic surgery
Exclusion Criteria:
Thoracoscopic esophagectomy Decortication for empyema
Sites / Locations
- National Taiwan University Hospital, Hsin-Chu Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Needlescopic-assisted
Uniportal
Arm Description
Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.
Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision
Outcomes
Primary Outcome Measures
Pain scale POD 3
Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)
Pain scale POD 5
Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)
Hospital stay
Post-operative hospital stay
Post-operative 3 month neuralgia
Out patient documented using PainDETECT questionnaire (PD-Q)
Post-operative 6 month neuralgia
Out patient documented using PainDETECT questionnaire (PD-Q)
Secondary Outcome Measures
Cost
Total hospital cost
Surgical time
Time spend in surgery
Surgical bleeding
Blood loss during operation
Opioid using dosage
Total opioid equivalent dose used during post-operative course
Full Information
NCT ID
NCT03439696
First Posted
February 7, 2018
Last Updated
February 24, 2021
Sponsor
IRB of NTUH Hsin-Chu Branch
1. Study Identification
Unique Protocol Identification Number
NCT03439696
Brief Title
Needlescopic-assisted Uniportal vs Uniportal VATS
Acronym
UNeed
Official Title
Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
IRB of NTUH Hsin-Chu Branch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Cancer Metastatic, Bullous Disease Lung, Nodule Solitary Pulmonary, Mediastinal Tumor
Keywords
Thoracoscopy, VATS, Needlescopy, Uniportal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Needlescopic-assisted
Arm Type
Experimental
Arm Description
Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.
Arm Title
Uniportal
Arm Type
Active Comparator
Arm Description
Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision
Intervention Type
Procedure
Intervention Name(s)
Thoracoscopic surgery
Intervention Description
Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.
Primary Outcome Measure Information:
Title
Pain scale POD 3
Description
Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)
Time Frame
3 days
Title
Pain scale POD 5
Description
Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)
Time Frame
5 days
Title
Hospital stay
Description
Post-operative hospital stay
Time Frame
14 days
Title
Post-operative 3 month neuralgia
Description
Out patient documented using PainDETECT questionnaire (PD-Q)
Time Frame
3 months
Title
Post-operative 6 month neuralgia
Description
Out patient documented using PainDETECT questionnaire (PD-Q)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cost
Description
Total hospital cost
Time Frame
14 days
Title
Surgical time
Description
Time spend in surgery
Time Frame
1 day
Title
Surgical bleeding
Description
Blood loss during operation
Time Frame
1 day
Title
Opioid using dosage
Description
Total opioid equivalent dose used during post-operative course
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lung or mediastinal disease requiring thoracoscopic surgery
Exclusion Criteria:
Thoracoscopic esophagectomy Decortication for empyema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-kuei Nien
Organizational Affiliation
National Taiwan University Hospital Hsinchu Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital, Hsin-Chu Branch
City
Taipei
State/Province
Hsin-Chu County
ZIP/Postal Code
30059
Country
Taiwan
12. IPD Sharing Statement
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Needlescopic-assisted Uniportal vs Uniportal VATS
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