Needlescopic-assisted Uniportal vs Uniportal VATS

Not Applicable

Completed

• Conditions: Bullous Disease Lung; Nodule Solitary Pulmonary; Lung Cancer Metastatic; Lung Cancer; Mediastinal Tumor
• Interventions: Procedure: Thoracoscopic surgery

• Registration Number: NCT03439696
• Lead Sponsor: IRB of NTUH Hsin-Chu Branch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-20
• Study Start: 2018-02-22
• Primary Completion: 2018-12-12
• Study Completion: 2019-04-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Lung or mediastinal disease requiring thoracoscopic surgery

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Exclusion Criteria

Thoracoscopic esophagectomy Decortication for empyema

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uniportal	Thoracoscopic surgery	Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision
Needlescopic-assisted	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.

Primary Outcome Measures

Name	Time	Method
Hospital stay	14 days	Post-operative hospital stay
Post-operative 3 month neuralgia	3 months	Out patient documented using PainDETECT questionnaire (PD-Q)
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)
Post-operative 6 month neuralgia	6 months	Out patient documented using PainDETECT questionnaire (PD-Q)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Taiwan University Hospital, Hsin-Chu Branch; 🇨🇳 Taipei, Hsin-Chu County, Taiwan