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Completed

NCT Number: NCT03439696

Needlescopic-assisted Uniportal vs Uniportal VATS

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.

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Key information

Conditions

Lung Cancer Bullous Disease Lung Lung Cancer Metastatic Lung Diseases Lung Neoplasms Mediastinal Diseases Mediastinal Neoplasms Mediastinal Tumor Neoplasms Neoplasms by Site Nodule Solitary Pulmonary Respiratory Tract Diseases Respiratory Tract Neoplasms Solitary Pulmonary Nodule Thoracic Diseases Thoracic Neoplasms

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Hsin-Chu Branch

Taipei, Hsin-Chu County, 30059, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion criteria

Thoracoscopic esophagectomy Decortication for empyema

Treatment and study plan

Thoracoscopic Surgery

Procedure

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Primary outcomes

  1. Pain scale POD 3

    Time frame: 3 days

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

  2. Pain scale POD 5

    Time frame: 5 days

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

  3. Hospital stay

    Time frame: 14 days

    Post-operative hospital stay

  4. Post-operative 3 month neuralgia

    Time frame: 3 months

    Out patient documented using PainDETECT questionnaire (PD-Q)

  5. Post-operative 6 month neuralgia

    Time frame: 6 months

    Out patient documented using PainDETECT questionnaire (PD-Q)

Secondary outcomes

  1. Cost

    Time frame: 14 days

    Total hospital cost

  2. Surgical time

    Time frame: 1 day

    Time spend in surgery

  3. Surgical bleeding

    Time frame: 1 day

    Blood loss during operation

  4. Opioid using dosage

    Time frame: 14 days

    Total opioid equivalent dose used during post-operative course

Sponsors and collaborators

Lead sponsor

IRB of NTUH Hsin-Chu Branch

Other

Registry information

Official study title

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

Acronym: UNeed

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 20, 2018
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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