Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Group

Patients with 2 standard chest tubes

Group Type ACTIVE_COMPARATOR

standard chest tubes

Intervention Type DEVICE

2 standard postoperative chest tube used

Coaxial Group

Patients with 1 coaxial tube

Group Type EXPERIMENTAL

coaxial chest tube

Intervention Type DEVICE

1 postoperative smart drain coaxial tube

Interventions

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standard chest tubes

2 standard postoperative chest tube used

Intervention Type DEVICE

coaxial chest tube

1 postoperative smart drain coaxial tube

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No