Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy
May 6, 2021 updated by: Marco Anile
Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy: a Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Roma, Italy
- Sapienza University of Rome
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age more than 18 years
- patients scheduled for pulmonary lobectomy
Exclusion Criteria:
- middle lobectomy,
- extended resections, minimally invasive lobectomies,
- previous ipsilateral thoracic surgery,
- induction chemo and/or radiotherapy
- patients who did not give consent to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Group
Patients with 2 standard chest tubes
|
2 standard postoperative chest tube used
|
|
Experimental: Coaxial Group
Patients with 1 coaxial tube
|
1 postoperative smart drain coaxial tube
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily fluid drainage (mL)
Time Frame: 1 postoperative day
|
Quality of fluid drainage evaluated in mL and by means of a chest X rays
|
1 postoperative day
|
|
Presence of postoperative pneumothorax
Time Frame: 1 postoperative day
|
Quality of air drainage evaluated by chest X rays
|
1 postoperative day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
presence of pneumothorax after tubes removal
Time Frame: within 24 hours after tubes removal
|
Pneumothorax evaluated by chest x rays
|
within 24 hours after tubes removal
|
|
evaluation of pain measured by Visual Analogue Scale
Time Frame: 1 postoperative day
|
evaluation of patient's pain with a 1 - 10 scale ( 0 no pain - 10 maximum pain)
|
1 postoperative day
|
|
Analysis of costs (in euros)
Time Frame: until discharge, an average of 6 days
|
Evaluation of hospital costs in euros during the hospitalization
|
until discharge, an average of 6 days
|
|
Postoperative hospitalization (in days)
Time Frame: until discharge, an average of 6 days
|
Duration of hospitalization in days after the operation
|
until discharge, an average of 6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Guerrera F, Filosso PL, Pompili C, Olivetti S, Roffinella M, Imperatori A, Brunelli A. Application of the coaxial smart drain in patients with a large air leak following anatomic lung resection: a prospective multicenter phase II analysis of efficacy and safety. J Vis Surg. 2018 Jan 29;4:26. doi: 10.21037/jovs.2018.01.07. eCollection 2018.
- Rena O, Parini S, Papalia E, Massera F, Turello D, Baietto G, Casadio C. The Redax(R) Coaxial Drain in pulmonary lobectomy: a study of efficacy. J Thorac Dis. 2017 Sep;9(9):3215-3221. doi: 10.21037/jtd.2017.08.110.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
April 27, 2021
First Submitted That Met QC Criteria
May 6, 2021
First Posted (Actual)
May 7, 2021
Study Record Updates
Last Update Posted (Actual)
May 7, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- COAXIAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.