Tubeless VATS for Peripheral Lung Nodule

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02817048

Collaborator

(none)

100

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solitary Pulmonary Nodule	Device: chest tube Procedure: VATS without chest tube placement Procedure: VATS with chest tube placement	N/A

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

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Sep 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Tubeless

Interventions: VATS without chest tube placement

Procedure: VATS without chest tube placement

Patient received Video-Assisted Thoracic Surgery (VATS) wedge resection for peripheral lung nodule without chest tube placement (Tubeless)

Active Comparator: Chest tube

VATS with chest tube placement

Device: chest tube

Procedure: VATS with chest tube placement

Outcome Measures

Primary Outcome Measures

Postoperative hospital stay [1 week]

Secondary Outcome Measures

Postoperative pain score [1 week]
Postoperative intercostal neuralgia [1 month]
Postoperative wound satisfaction [1 month]

Other Outcome Measures

Hospital cost [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Study Director: Jin-Shing Chen, MD, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT02817048

Other Study ID Numbers:

201603030RIND

First Posted:

Jun 29, 2016

Last Update Posted:

Jun 29, 2016

Last Verified:

Jun 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Study Results

No Results Posted as of Jun 29, 2016