Lung Cancer
Conditions
Brief summary
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.
Interventions
DEVICEstandard chest tubes
2 standard postoperative chest tube used
DEVICEcoaxial chest tube
1 postoperative smart drain coaxial tube
Sponsors
Marco Anile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily fluid drainage (mL) | 1 postoperative day | Quality of fluid drainage evaluated in mL and by means of a chest X rays |
| Presence of postoperative pneumothorax | 1 postoperative day | Quality of air drainage evaluated by chest X rays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| presence of pneumothorax after tubes removal | within 24 hours after tubes removal | Pneumothorax evaluated by chest x rays |
| evaluation of pain measured by Visual Analogue Scale | 1 postoperative day | evaluation of patient's pain with a 1 - 10 scale ( 0 no pain - 10 maximum pain) |
| Analysis of costs (in euros) | until discharge, an average of 6 days | Evaluation of hospital costs in euros during the hospitalization |
| Postoperative hospitalization (in days) | until discharge, an average of 6 days | Duration of hospitalization in days after the operation |
Countries
Italy
Outcome results
None listed