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Medical Thoracoscopy Versus Tube Thoracostomy in Management of Empyema .

Primary Purpose

Empyema

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medical thoracoscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Empyema focused on measuring medical, Thoracoscopy, loculated, empyema

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. unilateral or bilateral frank pleural empyema (pus) .
  2. age > 18 and <70 years old

Exclusion Criteria:

  1. Transudative pleural effusion.
  2. Bleeding disorders.
  3. Hemo-dynamically unstable patients.
  4. General contraindications to thoracoscopy e.g. unstable angina, left ventricular failure, uncontrolled hypertension, bleeding tendency. . .etc.
  5. Recent history of chest trauma or proved hemothorax.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    empyema patients having medical thoracoscopy

    tube thoracostomy in patients with empyema

    Arm Description

    patients having empyema will undergo medical thoracoscopy as follow : With the closed biopsy forceps, step by step, fibrinous septae will be perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken & If no lesion, biopsy from parietal pleura was obtained from any sites. the intervention : is breaking the septation within the loculated empyema

    after confirmation of diagnosis of empyema Following , a chest tube (gauge 26-28) will be introduced and connected to underwater seal. The wound was then closed around the tube by stitches to fix it in position.

    Outcomes

    Primary Outcome Measures

    Medical cure without secondary Intervention
    medical cure will be defined as radiologic confirmation of successful pleural drainage (i.e. reduction of the size of the pleural fluid on the chest X-ray and chest ultrasound )with no need for further treatment by r surgical interventions) objective evidence of sepsis resolution (improvement in temperature and clinical condition and decreasing inflammatory laboratory markers .and decrease of amount of fluid discharge less than (50-100)cc per day .

    Secondary Outcome Measures

    Duration of hospital stay
    Reduction in hospital stay in group with medical thoracoscopy in comparison to the group with simple chest tube
    Adverse events
    such as bleeding , sever pain , persistence air leak

    Full Information

    First Posted
    February 19, 2019
    Last Updated
    March 1, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03859206
    Brief Title
    Medical Thoracoscopy Versus Tube Thoracostomy in Management of Empyema .
    Official Title
    A Comparative Study : Medical Thoracoscopy Versus Tube Thoracostomy in Early Management of Empyema .
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    May 1, 2021 (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

    5. Study Description

    Brief Summary
    Pleural empyema : is a collection of pus in the pleural cavity caused by microorganisms, usually bacteria.[1] Medical thoracoscopy has played a marginal role in the treatment of empyema for a long time, but has become more and more established in recent years. It can be per-formed in analgo-sedation in a bronchoscopy suite. It is minimally invasive and costs are much lower compared to surgical VATS. The diagnostic and therapeutic power seems to be comparable to VATS, since several studies show success rates with medical thoracoscopy between 73 and 100% (2, 3) .
    Detailed Description
    Study Setting: Assuit university hospital - Chest department. endoscopy unit . the subjects will under go the following : Thorough medical history . Routine hematologic investigations . Pleural fluid aspiration and analyses . . Radiological investigation & Chest X ray and CT scan to localize pleural fluid collection and assess the echogenicity of the effusion. & Chest ultrasound. Loculated empyema defined as ultrasonographic presence of empyema loculations with presence of intrapleural septa. Medical thoracoscopy (MT): Medical thoracoscopy with single-port-of-entry technique will be performed in the bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg) or bethdein. To define the point of entry into the pleural cavity, an ultrasound will be carried out. vertical incision will be made with the scalpel (usually near the midaxillary line), through the skin and subcutaneous tissue, appropriate to the size of the trocar to be used, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space. Then the trocar will be inserted in a corkscrew motion until the sudden release of resistance (after passing the costal pleura) is felt, while holding the handle of the trocar firmly in the palm of the hand, as index finger is extended. Under direct vision with the thoracoscope, introduction of pneumothorax will be performed, and all pleural fluid will be removed, and the pleural cavity will be inspected. With the closed biopsy forceps, step by step, fibrinous septae were perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken & If no lesion, biopsy from parietal pleura was obtained from any sites. & Following thoracoscopy, a chest tube (gauge 26-28) was introduced and connected to underwater seal. The wound was then closed around the tube by stitches to fix it in position. & After the procedure, chest X- ray PA view was done to show if any complications had happened and to insure inflation of the lung, to determine the size of the residual pneumothorax. Vital signs were recorded at appropriate intervals for 24 h. & The rigid thoracoscope and its accessories were sterilized by cold immersion in 2% gultraldhyde (cidex) for at least 30 min. An intercostal drain will be placed with underwater seal drainage to drain residual air and fluid from the pleural cavity, allowing the lung to re expand. The indications for removal of chest tubes will be absence of air leakage and cessation of fluid flow (100-150 mL daily). The patients who would be diagnosed will be blindly randomized to the two study arms : medical thoracoscopy or tube thoracostomy .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Empyema
    Keywords
    medical, Thoracoscopy, loculated, empyema

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    empyema patients having medical thoracoscopy
    Arm Type
    Experimental
    Arm Description
    patients having empyema will undergo medical thoracoscopy as follow : With the closed biopsy forceps, step by step, fibrinous septae will be perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken & If no lesion, biopsy from parietal pleura was obtained from any sites. the intervention : is breaking the septation within the loculated empyema
    Arm Title
    tube thoracostomy in patients with empyema
    Arm Type
    No Intervention
    Arm Description
    after confirmation of diagnosis of empyema Following , a chest tube (gauge 26-28) will be introduced and connected to underwater seal. The wound was then closed around the tube by stitches to fix it in position.
    Intervention Type
    Other
    Intervention Name(s)
    Medical thoracoscopy
    Intervention Description
    • With the closed biopsy forceps, step by step, fibrinous septae were perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken & If no lesion, biopsy from parietal pleura was obtained from any sites.
    Primary Outcome Measure Information:
    Title
    Medical cure without secondary Intervention
    Description
    medical cure will be defined as radiologic confirmation of successful pleural drainage (i.e. reduction of the size of the pleural fluid on the chest X-ray and chest ultrasound )with no need for further treatment by r surgical interventions) objective evidence of sepsis resolution (improvement in temperature and clinical condition and decreasing inflammatory laboratory markers .and decrease of amount of fluid discharge less than (50-100)cc per day .
    Time Frame
    up to 14 days .
    Secondary Outcome Measure Information:
    Title
    Duration of hospital stay
    Description
    Reduction in hospital stay in group with medical thoracoscopy in comparison to the group with simple chest tube
    Time Frame
    up to 14 day .
    Title
    Adverse events
    Description
    such as bleeding , sever pain , persistence air leak
    Time Frame
    within 24 hour after medical thoracoscopy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: unilateral or bilateral frank pleural empyema (pus) . age > 18 and <70 years old Exclusion Criteria: Transudative pleural effusion. Bleeding disorders. Hemo-dynamically unstable patients. General contraindications to thoracoscopy e.g. unstable angina, left ventricular failure, uncontrolled hypertension, bleeding tendency. . .etc. Recent history of chest trauma or proved hemothorax.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    shahenda mohammed gamal el din, MD
    Phone
    01009190918
    Email
    elkadyshahenda@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed M.Reda Abdelaziz, MD
    Phone
    01007041335
    Email
    m_reda306@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28304084
    Citation
    Redden MD, Chin TY, van Driel ML. Surgical versus non-surgical management for pleural empyema. Cochrane Database Syst Rev. 2017 Mar 17;3(3):CD010651. doi: 10.1002/14651858.CD010651.pub2.
    Results Reference
    background
    PubMed Identifier
    16304276
    Citation
    Brutsche MH, Tassi GF, Gyorik S, Gokcimen M, Renard C, Marchetti GP, Tschopp JM. Treatment of sonographically stratified multiloculated thoracic empyema by medical thoracoscopy. Chest. 2005 Nov;128(5):3303-9. doi: 10.1378/chest.128.5.3303.
    Results Reference
    background

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    Medical Thoracoscopy Versus Tube Thoracostomy in Management of Empyema .

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