Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS

Study Overview
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Brief Summary
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The aim of the study is to evaluate efficacy and safety of Smart Coaxial drain (Redax TM, Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's comfort in Uniportal- and Biportal-VATS upper lobectomies. In particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of smart coaxial drains compared with standard silicone chest tubes.

Detailed Description
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At the end of lung surgery, usually surgeons placed one or more chest tubes. There are several types of chest tubes and the type used by surgeons depends on centre avaiability/ local practice or surgeon choice etc...Coaxial smart drains are used in clinical practice since several years in Thoracic Surgery. In thoracoscopic (VATS) surgery usually only one chest tube is placed. In this study, we evaluate the efficacy of placement of 28Fr coaxial smart drain chest tube versus 28 Fr standard chest tube after Uniportal- or Biportal-VATS upper lobectomies in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's confort.

Official Title
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Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS

Conditions
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Pleural Effusion, Video Assisted Thoracic Surgery, Chest Tubes

Intervention / Treatment
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* Procedure: 28Fr coaxial smart drain chest tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS Exclusion Criteria: Patients undergone open surgery Patients undergone middle or lower lobectomies Patients undergone chest wall/or wedge resections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery | Procedure: 28Fr coaxial smart drain chest tube<br>* To evaluate the efficacy of one 28Fr chest tube (coaxial smart drain versus standard chest tube according to local practice, types of drainage availability in each centre, surgeon's choice etc) after Uniportal- or Biportal-VATS upper lobectomies.<br>|
| No Intervention: Study group 1<br>All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery | |
| Experimental: Study group 2<br>All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery | Procedure: 28Fr coaxial smart drain chest tube<br>* To evaluate the efficacy of one 28Fr chest tube (coaxial smart drain versus standard chest tube according to local practice, types of drainage availability in each centre, surgeon's choice etc) after Uniportal- or Biportal-VATS upper lobectomies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid output 1 | Total fluid amount | At 24 hours from surgery | 
| Fluid output 2 | Total fluid amount | At 48 hours from surgery | 
| Fluid output 3 | Total fluid amount | At 72 hours from surgery | 
| Fluid output 4 | Total fluid amount | At 96 hours from surgery | 
| Residual pleural effusion at chest X-Ray | Residual pleural effusion at chest X-Ray before chest tube removal. The entity of pleural effusion is measured as intercostal spaces, counted on posterior costal arches | 72 hours after surgery | 
| subcutaneous emphysema 1 | incidence of subcutaneous emphysema | At 24 hours after surgery | 
| subcutaneous emphysema 2 | incidence of subcutaneous emphysema | At 48 hours after surgery | 
| subcutaneous emphysema 3 | incidence of subcutaneous emphysema | At 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tube obstruction | tube obstructed by blood clots | during chest tube removal procedure | 
| Pain related to chest tube 1 | Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain) | At 24 hours after surgery | 
| Pain related to chest tube 2 | Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain) | At 48 hours after surgery | 
| Pain related to chest tube 3 | Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain) | At 72 hours after surgery | 
| Pain related to chest tube 4 | Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain) | At 96 hours after surgery |