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CompletedNCT03439696UNeedUpdated Feb 25, 2021

Needlescopic-assisted Uniportal vs Uniportal VATS

An interventional study of Thoracoscopic surgery in Lung Cancer, Lung Cancer Metastatic and Bullous Disease Lung, sponsored by IRB of NTUH Hsin-Chu Branch. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-25.

Sponsored by IRB of NTUH Hsin-Chu Branch · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer
  • Lung Cancer Metastatic
  • Bullous Disease Lung
  • Nodule Solitary Pulmonary
  • Mediastinal Tumor

Keywords

  • Thoracoscopy
  • VATS
  • Needlescopy
  • Uniportal
03

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion criteria

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
110 participants (actual)

Study arms

  • 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

  • Active comparator
    Uniportal

    Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision

    Procedure: Thoracoscopic surgery

Interventions

  • ProcedureThoracoscopic surgery

    Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

05

What researchers measure

Primary outcomes

  1. Pain scale POD 3

    Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)

    Time frame: 3 days

  2. Pain scale POD 5

    Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)

    Time frame: 5 days

  3. Hospital stay

    Post-operative hospital stay

    Time frame: 14 days

  4. Post-operative 3 month neuralgia

    Out patient documented using PainDETECT questionnaire (PD-Q)

    Time frame: 3 months

  5. Post-operative 6 month neuralgia

    Out patient documented using PainDETECT questionnaire (PD-Q)

    Time frame: 6 months

Secondary outcomes

  1. Cost

    Total hospital cost

    Time frame: 14 days

  2. Surgical time

    Time spend in surgery

    Time frame: 1 day

  3. Surgical bleeding

    Blood loss during operation

    Time frame: 1 day

  4. Opioid using dosage

    Total opioid equivalent dose used during post-operative course

    Time frame: 14 days

06

Study locations

1 site
  • National Taiwan University Hospital, Hsin-Chu Branch
    Taipei, Hsin-Chu County 30059, Taiwan
07

Registry details

Key details

Study ID
NCT03439696
Lead sponsor
IRB of NTUH Hsin-Chu Branch
Responsible party
IRB of NTUH Hsin-Chu Branch (National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch) — Sponsor-investigator
First posted
Feb 20, 2018
Start date
Feb 22, 2018
Primary completion
Dec 12, 2018
Completion
Apr 30, 2019
Last update
Feb 25, 2021

Study contacts

Chiu-kuei Nien
principal investigator · National Taiwan University Hospital Hsinchu Branch

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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