Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy
NCT04877925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2021-05-07
Summary
Objectives: Chest tubes are routinely inserted after thoracic surgery procedures in different size and numbers. The aim of this study is to assess the efficacy of Smart Drain Coaxial drainage compared with two standard chest tubes in patients undergoing thoracotomy for pulmonary lobectomy. 98 patients (57 males and 41 females, mean age 68.3±7.4 years) with lung cancer undergoing open pulmonary lobectomy were randomized in two groups: 50 received one upper 28-Fr and one lower 32-Fr standard chest tube (ST group) and 48 received one 28-Fr Smart Drain Coaxial tube (CT group). Hospitalization data, quantity of fluid output, air leaks, radiograph findings, pain control and costs were assessed.
Conditions
Interventions
- DEVICE
-
standard chest tubes
2 standard postoperative chest tube used
- DEVICE
-
coaxial chest tube
1 postoperative smart drain coaxial tube
Sponsors & Collaborators
-
Marco Anile
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-01
- Primary Completion
- 2018-04-30
- Completion
- 2020-11-30
Countries
- Italy
Study Locations
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