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Completed

NCT Number: NCT04877925

Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard chest tubes

Device

2 standard postoperative chest tube used

coaxial chest tube

Device

1 postoperative smart drain coaxial tube

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Marco Anile

Other

Registry information

Official study title

Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy: a Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
May 7, 2021
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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