NCT03439696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 22, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

February 7, 2018

Last Update Submit

February 24, 2021

Conditions

Lung CancerLung Cancer MetastaticBullous Disease LungNodule Solitary PulmonaryMediastinal Tumor

Keywords

ThoracoscopyVATSNeedlescopyUniportal

Outcome Measures

Primary Outcomes (5)

  • Pain scale POD 3

    Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)

    3 days

  • Pain scale POD 5

    Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)

    5 days

  • Hospital stay

    Post-operative hospital stay

    14 days

  • Post-operative 3 month neuralgia

    Out patient documented using PainDETECT questionnaire (PD-Q)

    3 months

  • Post-operative 6 month neuralgia

    Out patient documented using PainDETECT questionnaire (PD-Q)

    6 months

Secondary Outcomes (4)

  • Cost

    14 days

  • Surgical time

    1 day

  • Surgical bleeding

    1 day

  • Opioid using dosage

    14 days

Study Arms (2)

Needlescopic-assisted

EXPERIMENTAL

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

Uniportal

ACTIVE COMPARATOR

Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision

Procedure: Thoracoscopic surgery

Interventions

Thoracoscopic surgeryPROCEDURE

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Needlescopic-assistedUniportal

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lung or mediastinal disease requiring thoracoscopic surgery

You may not qualify if:

  • Thoracoscopic esophagectomy Decortication for empyema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Hsin-Chu Branch

Taipei, Hsin-Chu County, 30059, Taiwan

Location

MeSH Terms

Conditions

Lung NeoplasmsSolitary Pulmonary NoduleMediastinal Neoplasms

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMediastinal DiseasesThoracic Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Chiu-kuei Nien

    National Taiwan University Hospital Hsinchu Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
National Taiwan University Hospital Hsin-Chu Branch

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 20, 2018

Study Start

February 22, 2018

Primary Completion

December 12, 2018

Study Completion

April 30, 2019

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

TW(1)