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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-05

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pleural Effusion Video Assisted Thoracic Surgery Chest Tubes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study group

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

Group Type EXPERIMENTAL

28Fr "coaxial smart drain" chest tube

Intervention Type PROCEDURE

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.

Study group 1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group 2

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

Group Type EXPERIMENTAL

28Fr "coaxial smart drain" chest tube

Intervention Type PROCEDURE

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.

Interventions

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28Fr "coaxial smart drain" chest tube

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.

Intervention Type PROCEDURE