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Needlescopic-assisted Uniportal vs Uniportal VATS (UNeed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439696
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Lung Cancer Metastatic Bullous Disease Lung Nodule Solitary Pulmonary Mediastinal Tumor Procedure: Thoracoscopic surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Pain scale POD 3 [ Time Frame: 3 days ]
    Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)

  2. Pain scale POD 5 [ Time Frame: 5 days ]
    Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)

  3. Hospital stay [ Time Frame: 14 days ]
    Post-operative hospital stay

  4. Post-operative 3 month neuralgia [ Time Frame: 3 months ]
    Out patient documented using PainDETECT questionnaire (PD-Q)

  5. Post-operative 6 month neuralgia [ Time Frame: 6 months ]
    Out patient documented using PainDETECT questionnaire (PD-Q)


Secondary Outcome Measures :
  1. Cost [ Time Frame: 14 days ]
    Total hospital cost

  2. Surgical time [ Time Frame: 1 day ]
    Time spend in surgery

  3. Surgical bleeding [ Time Frame: 1 day ]
    Blood loss during operation

  4. Opioid using dosage [ Time Frame: 14 days ]
    Total opioid equivalent dose used during post-operative course


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439696


Locations
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Taiwan
National Taiwan University Hospital, Hsin-Chu Branch
Taipei, Hsin-Chu County, Taiwan, 30059
Sponsors and Collaborators
IRB of NTUH Hsin-Chu Branch
Investigators
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Principal Investigator: Chiu-kuei Nien National Taiwan University Hospital Hsinchu Branch
More Information
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Responsible Party: IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch
ClinicalTrials.gov Identifier: NCT03439696    
Other Study ID Numbers: 106-067-F
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch:
Thoracoscopy
VATS
Needlescopy
Uniportal
Additional relevant MeSH terms:
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Lung Neoplasms
Mediastinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mediastinal Diseases
Thoracic Diseases