UNeed: Needlescopic-assisted Uniportal vs Uniportal VATS

Sponsor

IRB of NTUH Hsin-Chu Branch (Other)

Overall Status

Completed

CT.gov ID

NCT03439696

Collaborator

(none)

110

Enrollment

Location

Arms

14.2

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Lung Cancer Metastatic Bullous Disease Lung Nodule Solitary Pulmonary Mediastinal Tumor	Procedure: Thoracoscopic surgery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 22, 2018

Actual Primary Completion Date :

Dec 12, 2018

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.
Active Comparator: Uniportal Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision	Procedure: Thoracoscopic surgery Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Arm

Intervention/Treatment

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

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Active Comparator: Uniportal

Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision

Procedure: Thoracoscopic surgery

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital, Hsin-Chu Branch	Taipei	Hsin-Chu County	Taiwan	30059

Sponsors and Collaborators

IRB of NTUH Hsin-Chu Branch

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch

ClinicalTrials.gov Identifier:

NCT03439696

Other Study ID Numbers:

106-067-F

First Posted:

Feb 20, 2018

Last Update Posted:

Feb 25, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch

Additional relevant MeSH terms:

Lung Neoplasms

Mediastinal Neoplasms

Study Results

No Results Posted as of Feb 25, 2021