Tubeless VATS for Peripheral Lung Nodule

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Solitary Pulmonary Nodule

Intervention / Treatment
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* Device: chest tube
* Procedure: VATS without chest tube placement
* Procedure: VATS with chest tube placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hospital stay |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score |  | 1 week | 
| Postoperative intercostal neuralgia |  | 1 month | 
| Postoperative wound satisfaction |  | 1 month |