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Small Catheter Drainage With Chest Tube Versus Chest Tube Alone After Uniport Video-assisted Thoracoscopic Procedures (uniportal VATS)

Primary Purpose

Lung Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
central venous catheter (small catheter drainage)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing uniport video-assisted thoracoscopic surgery at Assiut University Hospital who need intercostal drainage postoperative

Exclusion Criteria:

  • Patients who do not need intercostal tube post operative

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Small catheter with chest tube after uniport vats

    Chest tube only after uniport vats

    Arm Description

    Insertion of small catheter drainage in the same opening with chest tube after uniport vats

    After uniport vats we put chest tube only

    Outcomes

    Primary Outcome Measures

    Number of participants with failure of initial intervention
    Number of participants with failure of initial intervention , Requiring a second intervention i.e.insert second tube

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2018
    Last Updated
    June 7, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03484663
    Brief Title
    Small Catheter Drainage With Chest Tube Versus Chest Tube Alone After Uniport Video-assisted Thoracoscopic Procedures
    Acronym
    uniportal VATS
    Official Title
    Small Catheter Drainage With Chest Tube After Uniport Video-assisted Thoracoscopic Procedures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    May 1, 2019 (Anticipated)
    Study Completion Date
    July 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Small catheter drainage with chest tube after uniport Video-assisted Thoracoscopic Procedures
    Detailed Description
    Traditionally an Intercostal Tube is applied intraoperative following VATS procedures to drain the remaining pneumothorax and residual effusion , some of the residual effusion can't drain by intercostal tube which lead to prolonged hospital stay hypothesis that putting an additional small catheter drainage at the most depended part of hemithoracic early removal of chest tube without add more pain or hospital stay to the patient.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    case of small catheter drainage with chest tube versus chest tube alone after uniport vats
    Masking
    Participant
    Masking Description
    patient who will do vats procedure
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Small catheter with chest tube after uniport vats
    Arm Type
    Experimental
    Arm Description
    Insertion of small catheter drainage in the same opening with chest tube after uniport vats
    Arm Title
    Chest tube only after uniport vats
    Arm Type
    No Intervention
    Arm Description
    After uniport vats we put chest tube only
    Intervention Type
    Device
    Intervention Name(s)
    central venous catheter (small catheter drainage)
    Intervention Description
    Insertion central venous catheter ( small catheter drainage ) after uniport vats to decrease hospital stay and to easy drainage after procedure
    Primary Outcome Measure Information:
    Title
    Number of participants with failure of initial intervention
    Description
    Number of participants with failure of initial intervention , Requiring a second intervention i.e.insert second tube
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing uniport video-assisted thoracoscopic surgery at Assiut University Hospital who need intercostal drainage postoperative Exclusion Criteria: Patients who do not need intercostal tube post operative
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ali Abdelraouf, residant
    Phone
    01004396639
    Email
    alioufa32@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hussien Elkhayat, lecturer
    Phone
    01005549653
    Email
    DR_khayat@hotmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Small Catheter Drainage With Chest Tube Versus Chest Tube Alone After Uniport Video-assisted Thoracoscopic Procedures

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