Tubeless VATS for Peripheral Lung Nodule

National Taiwan University

Status: Unknown

Conditions: Solitary Pulmonary Nodule

Treatments: Procedure: VATS without chest tube placement; Device: chest tube; Procedure: VATS with chest tube placement

Study type: Interventional

Funder types: Other

Identifiers

NCT02817048

201603030RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Tubeless

Active Comparator group

Description:

Interventions: VATS without chest tube placement

Treatment:

Procedure: VATS without chest tube placement

Chest tube

Active Comparator group

Description:

VATS with chest tube placement

Treatment:

Device: chest tube

Procedure: VATS with chest tube placement