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Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04877925
Recruitment Status : Completed
First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Marco Anile, University of Roma La Sapienza

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: standard chest tubes Device: coaxial chest tube Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy: a Randomized Controlled Study
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Group
Patients with 2 standard chest tubes
 Device: standard chest tubes
2 standard postoperative chest tube used
Experimental: Coaxial Group
Patients with 1 coaxial tube
 Device: coaxial chest tube
1 postoperative smart drain coaxial tube


Outcome Measures
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Primary Outcome Measures :
  1. Daily fluid drainage (mL) [ Time Frame: 1 postoperative day ]
    Quality of fluid drainage evaluated in mL and by means of a chest X rays

  2. Presence of postoperative pneumothorax [ Time Frame: 1 postoperative day ]
    Quality of air drainage evaluated by chest X rays


Secondary Outcome Measures :
  1. presence of pneumothorax after tubes removal [ Time Frame: within 24 hours after tubes removal ]
    Pneumothorax evaluated by chest x rays

  2. 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)

  3. Analysis of costs (in euros) [ Time Frame: until discharge, an average of 6 days ]
    Evaluation of hospital costs in euros during the hospitalization

  4. Postoperative hospitalization (in days) [ Time Frame: until discharge, an average of 6 days ]
    Duration of hospitalization in days after the operation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877925


Locations
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Italy
Sapienza University of Rome
Roma, Italy
Sponsors and Collaborators
Marco Anile
More Information
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Publications of Results:

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Responsible Party: Marco Anile, Principal Investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04877925    
Other Study ID Numbers: COAXIAL
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No