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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
178
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Fluid output 1
Total fluid amount
Time frame: At 24 hours from surgery
Fluid output 2
Total fluid amount
Time frame: At 48 hours from surgery
Fluid output 3
Total fluid amount
Time frame: At 72 hours from surgery
Fluid output 4
Total fluid amount
Time frame: 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
Time frame: 72 hours after surgery
subcutaneous emphysema 1
incidence of subcutaneous emphysema
Time frame: At 24 hours after surgery
subcutaneous emphysema 2
incidence of subcutaneous emphysema
Time frame: At 48 hours after surgery
subcutaneous emphysema 3
incidence of subcutaneous emphysema
Time frame: At 72 hours after surgery
Tube obstruction
tube obstructed by blood clots
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At 96 hours after surgery
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