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Needlescopic-assisted Uniportal vs Uniportal VATS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03439696
Acronym
UNeed
Enrollment
110
Registered
2018-02-20
Start date
2018-02-22
Completion date
2019-04-30
Last updated
2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Thoracoscopy, VATS, Needlescopy, Uniportal

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.

Interventions

PROCEDUREThoracoscopic surgery

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Sponsors

IRB of NTUH Hsin-Chu Branch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion criteria

Thoracoscopic esophagectomy Decortication for empyema

Design outcomes

Primary

MeasureTime frameDescription
Post-operative 6 month neuralgia6 monthsOut patient documented using PainDETECT questionnaire (PD-Q)
Pain scale POD 33 daysPost-operative day 3 pain scale documented using Visual Analogue Scale (VAS)
Pain scale POD 55 daysPost-operative day 5 pain scale documented using Visual Analogue Scale (VAS)
Hospital stay14 daysPost-operative hospital stay
Post-operative 3 month neuralgia3 monthsOut patient documented using PainDETECT questionnaire (PD-Q)

Secondary

MeasureTime frameDescription
Surgical time1 dayTime spend in surgery
Surgical bleeding1 dayBlood loss during operation
Opioid using dosage14 daysTotal opioid equivalent dose used during post-operative course
Cost14 daysTotal hospital cost

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026