Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Video Assisted Thoracic Surgery; Pleural Effusion; Chest Tubes

Treatments: Procedure: 28Fr "coaxial smart drain" chest tube

Study type: Interventional

Funder types: Other

Identifiers

NCT06036667

ID 2388

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 3 patient groups

Study group

Experimental group

Description:

All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery

Treatment:

Procedure: 28Fr "coaxial smart drain" chest tube

Study group 1

No Intervention group

Description:

All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery

Study group 2

Experimental group

Description:

All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery

Treatment:

Procedure: 28Fr "coaxial smart drain" chest tube