NCT02817048

Brief Summary

Chest tube placement after thoracoscopy surgery had been generally accepted as routine procedure for removal of the residual intrapleural fluid and air, however, it would cause post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay. According to the recent studies, omission of chest tube placement after minor thoracoscopic procedures (such as pulmonary wedge resection) had been safe and feasible, and it also reduced the post-operative pain and shortened the hospital stay. We will conduct a prospective randomized trial in National Taiwan University Hospital.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Status
unknown

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

Study Start

First participant enrolled

June 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

June 27, 2016

Last Update Submit

June 28, 2016

Conditions

Solitary Pulmonary Nodule

Outcome Measures

Primary Outcomes (1)

  • Postoperative hospital stay

    1 week

Secondary Outcomes (3)

  • Postoperative pain score

    1 week

  • Postoperative intercostal neuralgia

    1 month

  • Postoperative wound satisfaction

    1 month

Other Outcomes (1)

  • Hospital cost

    1 week

Study Arms (2)

Tubeless

ACTIVE COMPARATOR

Interventions: VATS without chest tube placement

Procedure: VATS without chest tube placement

Chest tube

ACTIVE COMPARATOR

VATS with chest tube placement

Device: chest tubeProcedure: VATS with chest tube placement

Interventions

chest tubeDEVICE
Chest tube
VATS without chest tube placementPROCEDURE

Patient received Video-Assisted Thoracic Surgery (VATS) wedge resection for peripheral lung nodule without chest tube placement (Tubeless)

Tubeless
VATS with chest tube placementPROCEDURE
Chest tube

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CT revealed peripheral lung nodule, with both size and depth less than 2 cm
  • Aged 20 to 80 years

You may not qualify if:

  • Patients with ventilatory defect
  • Previous ipsilateral thoracic surgery
  • Bleeding tendency or anticoagulant use
  • Comorbidity including congestive heart failure, liver cirrhosis, chronic renal disease
  • Pregnancy or breast feeding
  • Immunocompromised or long-term steroid use
  • Severe infected patient
  • Patient who can not sign permit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083.

    PMID: 15511470RESULT

  • Rocco G, Romano V, Accardo R, Tempesta A, La Manna C, La Rocca A, Martucci N, D' Aiuto M, Polimeno E. Awake single-access (uniportal) video-assisted thoracoscopic surgery for peripheral pulmonary nodules in a complete ambulatory setting. Ann Thorac Surg. 2010 May;89(5):1625-7. doi: 10.1016/j.athoracsur.2010.01.087.

    PMID: 20417792RESULT

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Interventions

Chest TubesThoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and SuppliesThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Jin-Shing Chen, MD, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jin-Shing Chen, MD, PhD

CONTACT

886-2-23123456chenjs@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 29, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

June 29, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share