Lung CancerNCT04877925
Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy
A study testing standard chest tubes and coaxial chest tube in people with Lung Cancer, run by Marco Anile at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- standard chest tubes and coaxial chest tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2017to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18 years
- patients scheduled for pulmonary lobectomy
Who cannot join
- middle lobectomy,
- extended resections, minimally invasive lobectomies,
- previous ipsilateral thoracic surgery,
- induction chemo and/or radiotherapy
- patients who did not give consent to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Cancer
- Being tested
- standard chest tubes, coaxial chest tube
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard chest tubesDevice
2 standard postoperative chest tube used
coaxial chest tubeDevice
1 postoperative smart drain coaxial tube
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | Active comparator | Patients with 2 standard chest tubes Receives: Device: standard chest tubes |
| Coaxial Group | Experimental | Patients with 1 coaxial tube Receives: Device: coaxial chest tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily fluid drainage (mL)
Quality of fluid drainage evaluated in mL and by means of a chest X rays
Measured: 1 postoperative day
Presence of postoperative pneumothorax
Quality of air drainage evaluated by chest X rays
Measured: 1 postoperative day
Secondary outcomes (4)
presence of pneumothorax after tubes removal
Pneumothorax evaluated by chest x rays
Measured: within 24 hours after tubes removal
evaluation of pain measured by Visual Analogue Scale
evaluation of patient's pain with a 1 - 10 scale ( 0 no pain - 10 maximum pain)
Measured: 1 postoperative day
Analysis of costs (in euros)
Evaluation of hospital costs in euros during the hospitalization
Measured: until discharge, an average of 6 days
Postoperative hospitalization (in days)
Duration of hospitalization in days after the operation
Measured: until discharge, an average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Feb 2017
- Primary completion30 Apr 2018
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco Anile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Anile, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877925
- Sponsor's protocol ID
- COAXIAL
- Status last verified
- May 2021
- First submitted
- 27 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29445612Rena 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.
PubMed 29221298
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04877925
- Acronym / sponsor ID
- COAXIAL
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Marco AnileUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Group | Active comparator | Device: standard chest tubesPatients with 2 standard chest tubes |
| Coaxial Group | Experimental | Device: coaxial chest tubePatients with 1 coaxial tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age more than 18 years
- patients scheduled for pulmonary lobectomy
Key exclusion criteria (5 listed)
- middle lobectomy,
- extended resections, minimally invasive lobectomies,
- previous ipsilateral thoracic surgery,
- induction chemo and/or radiotherapy
- patients who did not give consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard chest tubes2 standard postoperative chest tube used | Device | Standard Group |
| coaxial chest tube1 postoperative smart drain coaxial tube | Device | Coaxial Group |
Primary outcome
Daily fluid drainage (mL)
Time frame: 1 postoperative day
Quality of fluid drainage evaluated in mL and by means of a chest X rays
Presence of postoperative pneumothorax
Time frame: 1 postoperative day
Quality of air drainage evaluated by chest X rays
4 secondary outcomes
presence of pneumothorax after tubes removal
Time frame: within 24 hours after tubes removal
evaluation of pain measured by Visual Analogue Scale
Time frame: 1 postoperative day
Analysis of costs (in euros)
Time frame: until discharge, an average of 6 days
Postoperative hospitalization (in days)
Time frame: until discharge, an average of 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Results publication: PubMed 29445612Guerrera 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.
- Results publication: PubMed 29221298Rena 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard chest tubes and coaxial chest tube in people with Lung Cancer, run by Marco Anile at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily fluid drainage (mL) (time frame: 1 postoperative day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.