The Affection of Two Chest Management for Enhanced Recovery Program After Video-assisted Thoracoscopic Lobectomy.

Study Overview
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Brief Summary
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Comparing the influences of different chest tube managements for enhanced recovery program after video-Assisted thoracoscopic lobectomy.

Detailed Description
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The Enhanced Recovery Program has a series of observation data contains hospitalization days, adverse events, drainage, extubation, visual analogue scale(VAS) scores and the number of analgesic using.The investigators plan to enroll 60 patients and divide them into two groups to compare the influences of different chest tube managements for enhanced recovery program after video-assisted thoracoscopic lobectomy.

Official Title
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Comparison of the Results of Two Chest Tube Management During an Enhanced Recovery Program After Video-Assisted Thoracoscopic Lobectomy.

Conditions
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Chest Tube

Intervention / Treatment
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* Other: Large size tube
* Other: Drainage ball


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Only single lesion on the targeted lobe Considered as invasive carcinoma by preoperative computed tomography (CT) or -diagnosed by intraoperative pathology Patients have signed informed consent. Exclusion Criteria: Patients have critical basic disease(diabetes and hypertension). Patients who lung function cannot undertake the lobectomy. The lesion has the possibility of metastasis. Finding serious adhesion to pleura during operation

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Total 60 patients accept video-Assisted thoracoscopic lobectomy are divided into two groups(Group A and Group B) equally and randomly.Different group takes different chest tube managements.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A:Group Tube<br>Patients are inserted the large size tube (28F).Patients undergo upper lobectomy are inserted one additional large size tube(28F,we named this tube upper tube).This group is planned to enroll 30 patients. | Other: Large size tube<br>* Patients in Group A are inserted the large size tube (28F).<br>* Other names: Upper tube;|
| Experimental: Group B:Group Ball<br>Patients are inserted the small size tube connects with a negative pressure ball(drainage ball).Patients undergo upper lobectomy are inserted one additional large size tube(28F,we named this tube upper tube).This group is planned to enroll 30 patients. | Other: Drainage ball<br>* Patients in Group B are inserted the small-bore tube connects with a negative pressure ball(drainage ball).<br>* Other names: Upper tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization days | The numbers of days of patients stay in the hospital after surgery | From the first days after surgery to discharge,up to 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS scores | VAS(Visual Analogue Score) is a method to value the degree of patient's pain after surgery.This method has a scale range from 1 to 10.Patient chose a number from it to represent his(her) pain.The 1 represents painless and the 10 represents sever pain which he(she) unable to bear. The pain is increasing with the increasing of number. | Pain is measured by VAS on the first 24 hours of after operation and the first 24 hours after tube removing. | 
| Analgesics | The number of analgesics using after surgery. | Counting the total analgesics using times through study completion, an average of 3 months. | 
| Drainage | The total volume of fluid. | Measure the volume every 24 hours,up to 4 weeks | 
| Pulmonary recruitment | Chest X-Ray | The first 24 hours after surgery and 8 hours before leaving hospital. | 
| Adverse event | Air-leakage or seepage from the surrounding of tube. | Counting the times of adverse events through study completion, an average of 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS(Enhanced Recovery After Surgery), Video-assisted thoracoscope lobectomy, Non-Small Cell Lung Cancer (NSCLC), Chest tube