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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Group | Active Comparator | Patients with 2 standard chest tubes |
|
| Coaxial Group | Experimental | Patients with 1 coaxial tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard chest tubes | Device | 2 standard postoperative chest tube used |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome | Roma | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29445612 | Result | Guerrera F, Filosso PL, Pompili C, Olivetti S, Roffinella M, Imperatori A, Brunelli A. Application of the coaxial smart drain in patients with a large air leak following anatomic lung resection: a prospective multicenter phase II analysis of efficacy and safety. J Vis Surg. 2018 Jan 29;4:26. doi: 10.21037/jovs.2018.01.07. eCollection 2018. | |
| 29221298 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| coaxial chest tube |
| Device |
1 postoperative smart drain coaxial tube |
|
| 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 |
| Rena O, Parini S, Papalia E, Massera F, Turello D, Baietto G, Casadio C. The Redax(R) Coaxial Drain in pulmonary lobectomy: a study of efficacy. J Thorac Dis. 2017 Sep;9(9):3215-3221. doi: 10.21037/jtd.2017.08.110. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |