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Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Chest Trauma

Primary Purpose

Thoracic Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video Assisted Thoracoscopic Surgery (VATS)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thoracic Injury

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: patient aged more than 13 yards old Hemo-dynamically stable patients with chest trauma Willing and able to provide written informed consent and comply with study requirements. Exclusion Criteria: patient aged less than 13 yards old. Hemo-dynamically instable patients Head trauma patients. missing informed consent Participation in another clinical research.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    case

    control

    Arm Description

    Use of vedio assisted thoracoscopic surgery in exploration in diagnosis and treatment of chest trauma patients whos heamodynamically stable

    exploratory thoracotomy inchest trauma patients in failure of vedio assisted thoracoscopic surgery or in haemodynamically instable patients

    Outcomes

    Primary Outcome Measures

    Duration of airleak, lung expansion and post operative bleeding.
    • Duration of complete healing: By Radiological (chest x-ray ant-post view and lat view & MSCT chest post-operative. Clinical examination post operative.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2023
    Last Updated
    September 13, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05991570
    Brief Title
    Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Chest Trauma
    Official Title
    Uni-portal Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Hemodynamically Stable Thoracic Trauma Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2025 (Anticipated)
    Study Completion Date
    January 15, 2026 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Video-assisted thoracic surgery has a standard role in diagnosis and therapy in thoracic surgery, In the past, most patients necessitating surgical treatment secondary to chest trauma was exposed to open thoracotomy, which was the most morbid of surgical incisions
    Detailed Description
    Video-assisted thoracoscopic surgery has become a popular and acceptable method for diagnosis of intra-thoracic lesions since 1990s with the developments in surgical techniques. It is also used for treatment of retained pleural collections, it is a simple alternative to open thoracotomy. Although it's multiple advantages, timing of surgery and its effects on patients' results are not well elucidated. Multiple studies report that prognosis of patients is better with the earlier interventions in injured chest. However, there is so many differences for the optimal time for surgery in these studies . Indications of VATS have been extended for management of diagnosis and treatment of chest trauma since 1990. This approach has multiple advantages as chest tube setting, minimally invasive surgery, less postoperative pain, and chest exploration. Today, VATS is used for empyema, persistent pneumothorax, retained haemothorax, mediastinal and diaphragmatic exploration, pleuro-pericardial ruptures, surgery for thoracic duct injury and aspiration of symptomatic foreign bodies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thoracic Injury

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    cohort study
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    case
    Arm Type
    Other
    Arm Description
    Use of vedio assisted thoracoscopic surgery in exploration in diagnosis and treatment of chest trauma patients whos heamodynamically stable
    Arm Title
    control
    Arm Type
    Other
    Arm Description
    exploratory thoracotomy inchest trauma patients in failure of vedio assisted thoracoscopic surgery or in haemodynamically instable patients
    Intervention Type
    Procedure
    Intervention Name(s)
    Video Assisted Thoracoscopic Surgery (VATS)
    Other Intervention Name(s)
    Thoracoscopic Exploration
    Intervention Description
    VATS is minimally invasive procedure for exploration to diagnose and treat thoracic injuries alternative to exploratory thoracotomy.
    Primary Outcome Measure Information:
    Title
    Duration of airleak, lung expansion and post operative bleeding.
    Description
    • Duration of complete healing: By Radiological (chest x-ray ant-post view and lat view & MSCT chest post-operative. Clinical examination post operative.
    Time Frame
    2 weaks postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patient aged more than 13 yards old Hemo-dynamically stable patients with chest trauma Willing and able to provide written informed consent and comply with study requirements. Exclusion Criteria: patient aged less than 13 yards old. Hemo-dynamically instable patients Head trauma patients. missing informed consent Participation in another clinical research.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    through international publication

    Learn more about this trial

    Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Chest Trauma

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