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

  • Italy
      • 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
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

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

Marco Anile

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

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.

Clinical Trials on Lung Cancer

Clinical Trials on standard chest tubes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe