Trials / Completed
CompletedNCT06036667
Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 178 (actual)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
Timeline
- Start date
- 2019-03-05
- Primary completion
- 2023-07-30
- Completion
- 2023-12-30
- First posted
- 2023-09-14
- Last updated
- 2024-02-28
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06036667. Inclusion in this directory is not an endorsement.