Needlescopic-assisted Uniportal vs Uniportal VATS

NCT ID: NCT03439696

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2019-04-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Thoracoscopic surgery

Intervention Type PROCEDURE

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Uniportal

Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision

Group Type ACTIVE_COMPARATOR

Thoracoscopic surgery

Intervention Type PROCEDURE

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Interventions

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Thoracoscopic surgery

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria

Thoracoscopic esophagectomy Decortication for empyema
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRB of NTUH Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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IRB of NTUH Hsin-Chu Branch

National Taiwan University Hospital Hsin-Chu Branch

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chiu-kuei Nien

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital Hsinchu Branch

Locations

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National Taiwan University Hospital, Hsin-Chu Branch

Taipei, Hsin-Chu County, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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106-067-F

Identifier Type: -

Identifier Source: org_study_id

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