Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

Study Overview
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Brief Summary
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Objectives: Chest tubes are routinely inserted after thoracic surgery procedures in different size and numbers. The aim of this study is to assess the efficacy of Smart Drain Coaxial drainage compared with two standard chest tubes in patients undergoing thoracotomy for pulmonary lobectomy. 98 patients (57 males and 41 females, mean age 68.3±7.4 years) with lung cancer undergoing open pulmonary lobectomy were randomized in two groups: 50 received one upper 28-Fr and one lower 32-Fr standard chest tube (ST group) and 48 received one 28-Fr Smart Drain Coaxial tube (CT group). Hospitalization data, quantity of fluid output, air leaks, radiograph findings, pain control and costs were assessed.

Official Title
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Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy: a Randomized Controlled Study

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: standard chest tubes
* Device: coaxial chest tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age more than 18 years patients scheduled for pulmonary lobectomy Exclusion Criteria: middle lobectomy, extended resections, minimally invasive lobectomies, previous ipsilateral thoracic surgery, induction chemo and/or radiotherapy patients who did not give consent to participate.

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Group<br>Patients with 2 standard chest tubes | Device: standard chest tubes<br>* 2 standard postoperative chest tube used<br>|
| Experimental: Coaxial Group<br>Patients with 1 coaxial tube | Device: coaxial chest tube<br>* 1 postoperative smart drain coaxial tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily fluid drainage (mL) | Quality of fluid drainage evaluated in mL and by means of a chest X rays | 1 postoperative day | 
| Presence of postoperative pneumothorax | Quality of air drainage evaluated by chest X rays | 1 postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of pneumothorax after tubes removal | Pneumothorax evaluated by chest x rays | within 24 hours after tubes removal | 
| evaluation of pain measured by Visual Analogue Scale | evaluation of patient's pain with a 1 - 10 scale ( 0 no pain - 10 maximum pain) | 1 postoperative day | 
| Analysis of costs (in euros) | Evaluation of hospital costs in euros during the hospitalization | until discharge, an average of 6 days | 
| Postoperative hospitalization (in days) | Duration of hospitalization in days after the operation | until discharge, an average of 6 days |