Clinical trial NCT06036667: Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
Official title: Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Video Assisted Thoracic Surgery
Chest Tubes
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fluid output 1
timeFrame: At 24 hours from surgery
measure: Fluid output 2
timeFrame: At 48 hours from surgery
measure: Fluid output 3
timeFrame: At 72 hours from surgery
measure: Fluid output 4
timeFrame: At 96 hours from surgery
measure: Residual pleural effusion at chest X-Ray
timeFrame: 72 hours after surgery
measure: subcutaneous emphysema 1
timeFrame: At 24 hours after surgery
measure: subcutaneous emphysema 2
timeFrame: At 48 hours after surgery
measure: subcutaneous emphysema 3
timeFrame: At 72 hours after surgery
Secondary outcomes:
measure: Tube obstruction
timeFrame: during chest tube removal procedure
measure: Pain related to chest tube 1
timeFrame: At 24 hours after surgery
measure: Pain related to chest tube 2
timeFrame: At 48 hours after surgery
measure: Pain related to chest tube 3
timeFrame: At 72 hours after surgery
measure: Pain related to chest tube 4
timeFrame: At 96 hours after surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Dania Nachira, MD
role: PRINCIPAL_INVESTIGATOR
References: