Second Stage EmpyemaICT and VATSNCT06680024
Comparative Study Between Outcome of ICT Drainage and VATS in Management of Second Stage Empyema
A study testing Intercostal tube and Video assisted thoracoscope in people with Second Stage Empyema, run by Sohag University.
Trial summary
The goal of this clinical trial is to compare between outcome of inter-costal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema. It compares the outcome of both interventions in hospital stay, cost, wether need of decortication later on or not. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Second Stage Empyema
- What is being tested?
- Intercostal tube and Video assisted thoracoscope
- 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
- 10 Nov 2024to 31 Jul 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients both adults and children diagnosed as Empyema thoracis in early stages based on clinical examination, imaging modalities and pleural fluid analysis
Who cannot join
- Empyema due to carcinoma, terminally ill patients, patients with severe respiratory distress at admission, patients not fit for surgery, patients with co morbid diseases like cardiac disorders and immunosuppression.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Outcome of Inter-costal Tube Drainage and Video Assisted Thoracoscopic Surgery in Management of Second Stage Empyema
The goal of this clinical trial is to compare between outcome of inter-costal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema.
It compares the outcome of both interventions in hospital stay, cost, wether need of decortication later on or not.
- Conditions
- Second Stage Empyema
- Being tested
- Intercostal tube, Video assisted thoracoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal tubeProcedure or surgery
Also called Chest tube
Intercostal tube drainage as a first management of second stage empyema
Video assisted thoracoscopeProcedure or surgery
Also called VATS
Video assisted thoracoscopic surgery as a first management for second stage empyema
| Study group | Role | What they receive |
|---|---|---|
| Intercostal tube | Active comparator | Intercostal tube as a primary intervention for treatment of second stage empyema Receives: Procedure: Intercostal tube |
| Video assisted thoracoscope | Active comparator | Video assisted thoracoscopic evacuation as a primary intervention for treatment of nd stage empyema Receives: Procedure: Video assisted thoracoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
the length of hospital stay
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare the length of hospital stay of each group of patients
Measured: From enrollment to 4 weeks
cost of treatment of the patients' in each group
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare cost of treatment of the patients' in each group
Measured: 4 weeks
number of participants with needs of decortication later on or not, assessed by the chest X-ray and CT chest.
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare with the chest X-ray and CT chest if there is residual empyema and whether the patients will need decortication later on or not
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Stage EmpyemaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Sayed Khalaf, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680024
- Sponsor's protocol ID
- Soh-Med-24-09-10MS
- Acronym
- ICT and VATS
- Status last verified
- Sep 2024
- First submitted
- 5 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Outcome of Inter-costal Tube Drainage and Video Assisted Thoracoscopic Surgery in Management of Second Stage Empyema
- ClinicalTrials.gov ID
- NCT06680024
- Acronym / sponsor ID
- ICT and VATS / Soh-Med-24-09-10MS
- Conditions
- Second Stage Empyema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 8 Nov 2024 (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.
The goal of this clinical trial is to compare between outcome of inter-costal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema.
It compares the outcome of both interventions in hospital stay, cost, wether need of decortication later on or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostal tube | Active comparator | Procedure: Intercostal tubeIntercostal tube as a primary intervention for treatment of second stage empyema |
| Video assisted thoracoscope | Active comparator | Procedure: Video assisted thoracoscopeVideo assisted thoracoscopic evacuation as a primary intervention for treatment of nd stage empyema |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients both adults and children diagnosed as Empyema thoracis in early stages based on clinical examination, imaging modalities and pleural fluid analysis
Key exclusion criteria (1 listed)
- Empyema due to carcinoma, terminally ill patients, patients with severe respiratory distress at admission, patients not fit for surgery, patients with co morbid diseases like cardiac disorders and immunosuppression.
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 |
|---|---|---|
| Intercostal tubeAlso: Chest tubeIntercostal tube drainage as a first management of second stage empyema | Procedure or surgery | Intercostal tube |
| Video assisted thoracoscopeAlso: VATSVideo assisted thoracoscopic surgery as a first management for second stage empyema | Procedure or surgery | Video assisted thoracoscope |
Primary outcome
the length of hospital stay
Time frame: From enrollment to 4 weeks
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare the length of hospital stay of each group of patients
cost of treatment of the patients' in each group
Time frame: 4 weeks
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare cost of treatment of the patients' in each group
number of participants with needs of decortication later on or not, assessed by the chest X-ray and CT chest.
Time frame: 4 weeks
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare with the chest X-ray and CT chest if there is residual empyema and whether the patients will need decortication later on or not
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing Intercostal tube and Video assisted thoracoscope in people with Second Stage Empyema, run by Sohag 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 1 inclusion and 1 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 8 Nov 2024. 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?
Contact Mostafa Sayed Khalaf (01027582257 ext. +20, Mostafasayed748@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the length of hospital stay (time frame: From enrollment to 4 weeks). The study lists 3 primary outcomes in all. 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 8 Nov 2024.