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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
IRB of NTUH Hsin-Chu Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Thoracoscopy, VATS, Needlescopy, Uniportal

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 7, 2018
Last Updated
February 24, 2021
Sponsor
IRB of NTUH Hsin-Chu Branch
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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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