Tubeless VATS for Peripheral Lung Nodule

June 28, 2016 updated by: National Taiwan University Hospital

Thoracoscopic Surgery Without Chest Tube Placement in Patients With Peripheral Lung Nodules: A Prospective Randomized Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We will enroll 100 patients with peripheral lung nodule who will be randomly assigned to no chest tube placement (tubeless group) or chest tube placement (control group) after thoracoscopic wedge resection with out without lymph adenectomy. The primary endpoints are to compare the post-operative hospital stay and post-operative pain sale between the two groups. The secondary endpoints are to compare the intercostal neuralgia and wound satisfaction one month after surgery between the two groups.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tubeless
Interventions: VATS without chest tube placement
Procedure: VATS without chest tube placement
Patient received Video-Assisted Thoracic Surgery (VATS) wedge resection for peripheral lung nodule without chest tube placement (Tubeless)
Active Comparator: Chest tube
VATS with chest tube placement
Device: chest tube
Procedure: VATS with chest tube placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative hospital stay
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain score
Time Frame: 1 week
1 week
Postoperative intercostal neuralgia
Time Frame: 1 month
1 month
Postoperative wound satisfaction
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Time Frame
Hospital cost
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Jin-Shing Chen, MD, PhD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201603030RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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