Needlescopic-assisted Uniportal vs Uniportal VATS

Lung Cancer Clinical Trial

— UNeed  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439696
• Other study ID #: 106-067-F
• Status: Completed
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2021
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 30, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Hsin-Chu Branch	Taipei	Hsin-Chu County

Sponsors (1)

Lead Sponsor	Collaborator
IRB of NTUH Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale POD 3	Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)	3 days
Primary	Pain scale POD 5	Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)	5 days
Primary	Hospital stay	Post-operative hospital stay	14 days
Primary	Post-operative 3 month neuralgia	Out patient documented using PainDETECT questionnaire (PD-Q)	3 months
Primary	Post-operative 6 month neuralgia	Out patient documented using PainDETECT questionnaire (PD-Q)	6 months
Secondary	Cost	Total hospital cost	14 days
Secondary	Surgical time	Time spend in surgery	1 day
Secondary	Surgical bleeding	Blood loss during operation	1 day
Secondary	Opioid using dosage	Total opioid equivalent dose used during post-operative course	14 days