NCT06036667

Brief Summary

The aim of the study is to evaluate efficacy and safety of "Smart Coaxial drain" (Redax TM, Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's comfort in Uniportal- and Biportal-VATS upper lobectomies. In particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of smart coaxial drains compared with standard silicone chest tubes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2023

Enrollment Period

4.4 years

First QC Date

February 21, 2023

Last Update Submit

February 26, 2024

Conditions

Pleural EffusionVideo Assisted Thoracic SurgeryChest Tubes

Outcome Measures

Primary Outcomes (8)

  • Fluid output 1

    Total fluid amount

    At 24 hours from surgery

  • Fluid output 2

    Total fluid amount

    At 48 hours from surgery

  • Fluid output 3

    Total fluid amount

    At 72 hours from surgery

  • Fluid output 4

    Total fluid amount

    At 96 hours from surgery

  • Residual pleural effusion at chest X-Ray

    Residual pleural effusion at chest X-Ray before chest tube removal. The entity of pleural effusion is measured as "intercostal spaces", counted on posterior costal arches

    72 hours after surgery

  • subcutaneous emphysema 1

    incidence of subcutaneous emphysema

    At 24 hours after surgery

  • subcutaneous emphysema 2

    incidence of subcutaneous emphysema

    At 48 hours after surgery

  • subcutaneous emphysema 3

    incidence of subcutaneous emphysema

    At 72 hours after surgery

Secondary Outcomes (5)

  • Tube obstruction

    during chest tube removal procedure

  • Pain related to chest tube 1

    At 24 hours after surgery

  • Pain related to chest tube 2

    At 48 hours after surgery

  • Pain related to chest tube 3

    At 72 hours after surgery

  • Pain related to chest tube 4

    At 96 hours after surgery

Study Arms (3)

Study group

EXPERIMENTAL

All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery

Procedure: 28Fr "coaxial smart drain" chest tube

Study group 1

NO INTERVENTION

All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery

Study group 2

EXPERIMENTAL

All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery

Procedure: 28Fr "coaxial smart drain" chest tube

Interventions

28Fr "coaxial smart drain" chest tubePROCEDURE

To evaluate the efficacy of one 28Fr chest tube ("coaxial smart drain" versus standard chest tube according to local practice, types of drainage availability in each centre, surgeon's choice etc) after Uniportal- or Biportal-VATS upper lobectomies.

Study groupStudy group 2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS

You may not qualify if:

  • Patients undergone open surgery
  • Patients undergone middle or lower lobectomies
  • Patients undergone chest wall/or wedge resections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Dania Nachira, MD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

September 14, 2023

Study Start

March 5, 2019

Primary Completion

July 30, 2023

Study Completion

December 30, 2023

Last Updated

February 28, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)