Clinical trial NCT02817048: Tubeless VATS for Peripheral Lung Nodule
Official title: Thoracoscopic Surgery Without Chest Tube Placement in Patients With Peripheral Lung Nodules: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solitary Pulmonary Nodule
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative hospital stay
timeFrame: 1 week
Secondary outcomes:
measure: Postoperative pain score
timeFrame: 1 week
measure: Postoperative intercostal neuralgia
timeFrame: 1 month
measure: Postoperative wound satisfaction
timeFrame: 1 month
Other outcomes:
measure: Hospital cost
timeFrame: 1 week
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Shing Chen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083.
citation: Rocco G, Romano V, Accardo R, Tempesta A, La Manna C, La Rocca A, Martucci N, D' Aiuto M, Polimeno E. Awake single-access (uniportal) video-assisted thoracoscopic surgery for peripheral pulmonary nodules in a complete ambulatory setting. Ann Thorac Surg. 2010 May;89(5):1625-7. doi: 10.1016/j.athoracsur.2010.01.087.