Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

Marco Anile

Status: Completed

Conditions: Lung Cancer

Treatments: Device: standard chest tubes; Device: coaxial chest tube

Study type: Interventional

Funder types: Other

Identifiers

NCT04877925

COAXIAL

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Standard Group

Active Comparator group

Description:

Patients with 2 standard chest tubes

Treatment:

Device: standard chest tubes

Coaxial Group

Experimental group

Description:

Patients with 1 coaxial tube

Treatment:

Device: coaxial chest tube