Tubeless VATS for Peripheral Lung Nodule

Not Applicable

• Conditions: Solitary Pulmonary Nodule
• Interventions: Procedure: VATS without chest tube placement; Device: chest tube; Procedure: VATS with chest tube placement

• Registration Number: NCT02817048
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Last Update Submitted: 2016-06-28
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Primary Completion: 2017-06
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chest tube	VATS with chest tube placement	VATS with chest tube placement
Tubeless	VATS without chest tube placement	Interventions: VATS without chest tube placement
Chest tube	chest tube	VATS with chest tube placement

Primary Outcome Measures

Name	Time	Method
Postoperative hospital stay	1 week

Secondary Outcome Measures

Name	Time	Method
Postoperative pain score	1 week
Postoperative intercostal neuralgia	1 month
Postoperative wound satisfaction	1 month