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

Not Applicable

Completed

• Conditions: Pleural Effusion; Video Assisted Thoracic Surgery; Chest Tubes
• Interventions: Procedure: 28Fr "coaxial smart drain" chest tube

• Registration Number: NCT06036667
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2019-03-05
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Primary Completion: 2023-07-30
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-14
• Study Completion: 2023-12-30
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	28Fr "coaxial smart drain" chest tube	All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery
Study group 2	28Fr "coaxial smart drain" chest tube	All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery

Primary Outcome Measures

Name	Time	Method
Fluid output 2	At 48 hours from surgery	Total fluid amount
Fluid output 3	At 72 hours from surgery	Total fluid amount
Fluid output 4	At 96 hours from surgery	Total fluid amount
Residual pleural effusion at chest X-Ray	72 hours after surgery	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
Fluid output 1	At 24 hours from surgery	Total fluid amount
subcutaneous emphysema 3	At 72 hours after surgery	incidence of subcutaneous emphysema
subcutaneous emphysema 1	At 24 hours after surgery	incidence of subcutaneous emphysema
subcutaneous emphysema 2	At 48 hours after surgery	incidence of subcutaneous emphysema

Secondary Outcome Measures

Name	Time	Method
Pain related to chest tube 4	At 96 hours after surgery	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)
Tube obstruction	during chest tube removal procedure	tube obstructed by blood clots
Pain related to chest tube 1	At 24 hours after surgery	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)
Pain related to chest tube 3	At 72 hours after surgery	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)
Pain related to chest tube 2	At 48 hours after surgery	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)

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy