Needlescopic-assisted Uniportal vs Uniportal VATS (UNeed)

February 24, 2021 updated by: IRB of NTUH Hsin-Chu Branch

Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Hsin-Chu County
      • Taipei, Hsin-Chu County, Taiwan, 30059
        • National Taiwan University Hospital, Hsin-Chu Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Needlescopic-assisted
Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.
Procedure: Thoracoscopic surgery
Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.
Active Comparator: Uniportal
Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision
Procedure: Thoracoscopic surgery
Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scale POD 3
Time Frame: 3 days
Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)
3 days
Pain scale POD 5
Time Frame: 5 days
Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)
5 days
Hospital stay
Time Frame: 14 days
Post-operative hospital stay
14 days
Post-operative 3 month neuralgia
Time Frame: 3 months
Out patient documented using PainDETECT questionnaire (PD-Q)
3 months
Post-operative 6 month neuralgia
Time Frame: 6 months
Out patient documented using PainDETECT questionnaire (PD-Q)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: 14 days
Total hospital cost
14 days
Surgical time
Time Frame: 1 day
Time spend in surgery
1 day
Surgical bleeding
Time Frame: 1 day
Blood loss during operation
1 day
Opioid using dosage
Time Frame: 14 days
Total opioid equivalent dose used during post-operative course
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRB of NTUH Hsin-Chu Branch

Investigators

  • Principal Investigator: Chiu-kuei Nien, National Taiwan University Hospital Hsinchu Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2018

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106-067-F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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