Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

NCT04877925 | Completed

• 1 other identifier: COAXIAL
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Daily fluid drainage (mL)

  Quality of fluid drainage evaluated in mL and by means of a chest X rays

  1 postoperative day

• Presence of postoperative pneumothorax

  Quality of air drainage evaluated by chest X rays

  1 postoperative day

Secondary Outcomes (4)

• presence of pneumothorax after tubes removal

  within 24 hours after tubes removal

• evaluation of pain measured by Visual Analogue Scale

  1 postoperative day

• Analysis of costs (in euros)

  until discharge, an average of 6 days

• Postoperative hospitalization (in days)

  until discharge, an average of 6 days

Study Arms (2)

Standard Group

ACTIVE COMPARATOR

Patients with 2 standard chest tubes

Device: standard chest tubes

Coaxial Group

EXPERIMENTAL

Patients with 1 coaxial tube

Device: coaxial chest tube

Interventions

standard chest tubes DEVICE

2 standard postoperative chest tube used

Standard Group

coaxial chest tube DEVICE

1 postoperative smart drain coaxial tube

Coaxial Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 18 years
• patients scheduled for pulmonary lobectomy

You may not qualify if:

• middle lobectomy,
• extended resections, minimally invasive lobectomies,
• previous ipsilateral thoracic surgery,
• induction chemo and/or radiotherapy
• patients who did not give consent to participate.

Sponsors & Collaborators

• Marco Anile: lead

Study Sites (1)

Sapienza University of Rome

Roma, Italy

Location

Related Publications (2)

• 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.

  PMID: 29445612 RESULT

• 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.

  PMID: 29221298 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 7, 2021
• Study Start: February 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: November 30, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

IT (1)