Thoracoscopic Surgery Without Chest Tube Placement in Patients With Peripheral Lung Nodules: A Prospective Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Primary Endpoint
- Postoperative hospital stay
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Chest tube
VATS with chest tube placement
Intervention: chest tube (Device)
Chest tube
VATS with chest tube placement
Intervention: VATS with chest tube placement (Procedure)
Tubeless
Interventions: VATS without chest tube placement
Intervention: VATS without chest tube placement (Procedure)
Outcomes
Primary Outcomes
Postoperative hospital stay
Time Frame: 1 week
Secondary Outcomes
- Postoperative pain score(1 week)
- Postoperative intercostal neuralgia(1 month)
- Postoperative wound satisfaction(1 month)