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
About this trial
This is an interventional diagnostic trial for Thoracic Injury
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.
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
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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