Needlescopic-assisted Uniportal vs Uniportal VATS

NCT03439696 — Not applicable, Completed, 110 participants, IRB of NTUH Hsin-Chu Branch

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

Registry	NCT03439696, acronym UNeed
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	110 (Actual)
Sponsor	IRB of NTUH Hsin-Chu Branch (Other)
Conditions	Lung Cancer, Lung Cancer Metastatic, Bullous Disease Lung, Nodule Solitary Pulmonary, Mediastinal Tumor
Interventions	Thoracoscopic surgery (Procedure)
Dates	start 2018-02-22, primary completion 2018-12-12, completion 2019-04-30, first posted 2018-02-20, last updated 2021-02-25
Locations	1 site in Taiwan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Needlescopic-assisted	Experimental	Procedure: Thoracoscopic surgery	Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.
Uniportal	Active comparator	Procedure: Thoracoscopic surgery	Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision

Thoracoscopic surgery (Procedure): Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 20 Years to 90 Years

Inclusion Criteria:

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema

+Locations (1)

Facility	City	Country	Status
National Taiwan University Hospital, Hsin-Chu Branch	Taipei, Hsin-Chu County	Taiwan

+Investigators

Chiu-kuei Nien, Principal investigator, National Taiwan University Hospital Hsinchu Branch