Thoracic InjuryNCT05991570
Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Chest Trauma
A study testing Video Assisted Thoracoscopic Surgery (VATS) in people with Thoracic Injury, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Injury
- What is being tested?
- Video Assisted Thoracoscopic Surgery (VATS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2023to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patient aged less than 13 yards old.
- Hemo-dynamically instable patients
- Head trauma patients.
- missing informed consent
- Participation in another clinical research.
About this study
Official title: Uni-portal Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Hemodynamically Stable Thoracic Trauma Patients
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
Read the 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.
- Conditions
- Thoracic Injury
- Being tested
- Video Assisted Thoracoscopic Surgery (VATS)
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Assisted Thoracoscopic Surgery (VATS)Procedure or surgery
Also called Thoracoscopic Exploration
VATS is minimally invasive procedure for exploration to diagnose and treat thoracic injuries alternative to exploratory thoracotomy.
| Study group | Role | What they receive |
|---|---|---|
| case | Other | Use of vedio assisted thoracoscopic surgery in exploration in diagnosis and treatment of chest trauma patients whos heamodynamically stable Receives: Procedure: Video Assisted Thoracoscopic Surgery (VATS) |
| control | Other | exploratory thoracotomy inchest trauma patients in failure of vedio assisted thoracoscopic surgery or in haemodynamically instable patients Receives: Procedure: Video Assisted Thoracoscopic Surgery (VATS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weaks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Dec 2023 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cohort study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hussein Rushdi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991570
- Sponsor's protocol ID
- AssiutCTS
- Status last verified
- Nov 2023
- First submitted
- 6 Aug 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: through international publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uni-portal Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Hemodynamically Stable Thoracic Trauma Patients
- ClinicalTrials.gov ID
- NCT05991570
- Acronym / sponsor ID
- AssiutCTS
- Conditions
- Thoracic Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- cohort study
| Arm | Type | Receives |
|---|---|---|
| case | Other | Procedure: Video Assisted Thoracoscopic Surgery (VATS)Use of vedio assisted thoracoscopic surgery in exploration in diagnosis and treatment of chest trauma patients whos heamodynamically stable |
| control | Other | Procedure: Video Assisted Thoracoscopic Surgery (VATS)exploratory thoracotomy inchest trauma patients in failure of vedio assisted thoracoscopic surgery or in haemodynamically instable patients |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- patient aged less than 13 yards old.
- Hemo-dynamically instable patients
- Head trauma patients.
- missing informed consent
- Participation in another clinical research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Assisted Thoracoscopic Surgery (VATS)Also: Thoracoscopic ExplorationVATS is minimally invasive procedure for exploration to diagnose and treat thoracic injuries alternative to exploratory thoracotomy. | Procedure or surgery | case, control |
Primary outcome
Duration of airleak, lung expansion and post operative bleeding.
Time frame: 2 weaks postoperative
• Duration of complete healing: By 1. Radiological (chest x-ray ant-post view and lat view \& MSCT chest post-operative. 2. Clinical examination post operative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. through international publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Video Assisted Thoracoscopic Surgery (VATS) in people with Thoracic Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of airleak, lung expansion and post operative bleeding. (time frame: 2 weaks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.