Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: standard chest tubes; Device: coaxial chest tube

• Registration Number: NCT04877925
• Lead Sponsor: Marco Anile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-04-30
• Study Completion: 2020-11-30
• Study First Submitted: 2021-04-27
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Study First Posted: 2021-05-07
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Group	standard chest tubes	Patients with 2 standard chest tubes
Coaxial Group	coaxial chest tube	Patients with 1 coaxial tube

Primary Outcome Measures

Name	Time	Method
Daily fluid drainage (mL)	1 postoperative day	Quality of fluid drainage evaluated in mL and by means of a chest X rays
Presence of postoperative pneumothorax	1 postoperative day	Quality of air drainage evaluated by chest X rays

Secondary Outcome Measures

Name	Time	Method
presence of pneumothorax after tubes removal	within 24 hours after tubes removal	Pneumothorax evaluated by chest x rays
evaluation of pain measured by Visual Analogue Scale	1 postoperative day	evaluation of patient's pain with a 1 - 10 scale ( 0 no pain - 10 maximum pain)
Analysis of costs (in euros)	until discharge, an average of 6 days	Evaluation of hospital costs in euros during the hospitalization
Postoperative hospitalization (in days)	until discharge, an average of 6 days	Duration of hospitalization in days after the operation

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Roma, Italy