Thoracic EmpyemaVATSNCT06424457
Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema
A study testing video assisted thoracoscopy (VATS) and open thoracotomy in people with Thoracic Empyema, run by Assiut University at 1 site in Egypt.
Trial summary
Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Thoracic Empyema
- What is being tested?
- video assisted thoracoscopy (VATS) and open thoracotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Apr 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric patients 1 yrs. : ≤ 18 yrs.
- Patients with empyema due to pneumonia.
- Patients with empyema had lasted for fewer than 3 weeks.
Who cannot join
- Patients < 1 yrs. old.
- Patients with whom pleural empyema had lasted for more than 3 weeks.
- Patients with empyema had been caused by trauma.
- Patients whose parents refuse to be included in the study.
- Patients with empyema due to ruptured lung abscess.
- Patients with empyema due to chest wall abscess.
Show all 9Show fewer
- Patients with empyema due to rib osteomyelitis.
- Patients with bronchopleural fistula.
- Patients with post-surgical empyema.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, +2088
ali zein elabdein, MD, +201014566896, ali_zein@aun.edu.eg
hussein Elkhayat, prof., +201005549653, elkhayat@aun.edu.eg
About this study
Official title: Video Assisted Thoracoscopic Surgery (VATS) Versus Thoracotomy in Management of Empyema in Pediatric Patients
Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications.
The aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (VATS) approach in comparison with thoracotomy in management of empyema in pediatric patients.
Read the detailed description
comparison between VATS decortication and open thoracotomy in cases of pediatric empyema
- Conditions
- Thoracic Empyema
- Being tested
- video assisted thoracoscopy (VATS), open thoracotomy
- Keywords
- pediatric empyema, VATS decortication
- Medical subject headings
- Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video assisted thoracoscopy (VATS)Procedure or surgery
the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy
open thoracotomyProcedure or surgery
the investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| group A (VATS) | Experimental | (group A) will receive VATS decortication as their definite management Receives: Procedure: video assisted thoracoscopy (VATS) |
| group B (open thoracotomy) | Experimental | (group B) will be assigned to open thoracotomy Receives: Procedure: open thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound size
by centimeters
Measured: after 1week post operative
wound infection
which degree of infection or if there is a burst wound
Measured: during 1week post operative
hospital stay
by days post operative
Measured: 1week post operative
air leak duration
by days and takes how many days to stop air leakage
Measured: during 1week post operative
pain score
through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)
Measured: during 1week post operative.
Early mobilization.
how many days
Measured: during 1week post operative
Secondary outcomes (3)
chronic pain
presented or not
Measured: after 1month post operative
avoidance of scoliosis
which degree
Measured: after 1month post operative
shoulder muscle girdle weakness and deformity.
yes or no
Measured: after 1month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thoracic EmpyemaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali zein elabdein abd elaleim, Assiut University
- Investigators
- Mohamed Ayyad, prof., Study director, professorMahmoud sallam, MD, Study director, doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424457
- Sponsor's protocol ID
- 04-2024-100227
- Acronym
- VATS
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnold DT, Hamilton FW, Morris TT, Suri T, Morley A, Frost V, Vipond IB, Medford AR, Payne RA, Muir P, Maskell NA. Epidemiology of pleural empyema in English hospitals and the impact of influenza. Eur Respir J. 2021 Jun 17;57(6):2003546. doi: 10.1183/13993003.03546-2020. Print 2021 Jun.
PubMed 33334937Krenke K, Urbankowska E, Urbankowski T, Lange J, Kulus M. Clinical characteristics of 323 children with parapneumonic pleural effusion and pleural empyema due to community acquired pneumonia. J Infect Chemother. 2016 May;22(5):292-7. doi: 10.1016/j.jiac.2016.01.016. Epub 2016 Feb 23.
PubMed 26919911Shojaee S, Lee HJ. Thoracoscopy: medical versus surgical-in the management of pleural diseases. J Thorac Dis. 2015 Dec;7(Suppl 4):S339-51. doi: 10.3978/j.issn.2072-1439.2015.11.66.
PubMed 26807282Bedawi EO, Hassan M, McCracken D, Rahman NM. Pleural infection: a closer look at the etiopathogenesis, microbiology and role of antibiotics. Expert Rev Respir Med. 2019 Apr;13(4):337-347. doi: 10.1080/17476348.2019.1578212. Epub 2019 Feb 20.
PubMed 30707629
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Assisted Thoracoscopic Surgery (VATS) Versus Thoracotomy in Management of Empyema in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06424457
- Acronym / sponsor ID
- VATS / 04-2024-100227
- Conditions
- Thoracic Empyema
- Keywords
- pediatric empyema, VATS decortication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 22 May 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.
Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications.
The aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (VATS) approach in comparison with thoracotomy in management of empyema in pediatric patients.
Detailed description
comparison between VATS decortication and open thoracotomy in cases of pediatric empyema
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A (VATS) | Experimental | Procedure: video assisted thoracoscopy (VATS)(group A) will receive VATS decortication as their definite management |
| group B (open thoracotomy) | Experimental | Procedure: open thoracotomy(group B) will be assigned to open thoracotomy |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- pediatric patients 1 yrs. : ≤ 18 yrs.
- Patients with empyema due to pneumonia.
- Patients with empyema had lasted for fewer than 3 weeks.
Key exclusion criteria (9 listed)
- Patients < 1 yrs. old.
- Patients with whom pleural empyema had lasted for more than 3 weeks.
- Patients with empyema had been caused by trauma.
- Patients whose parents refuse to be included in the study.
- Patients with empyema due to ruptured lung abscess.
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 thoracoscopy (VATS)the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy | Procedure or surgery | group A (VATS) |
| open thoracotomythe investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy | Procedure or surgery | group B (open thoracotomy) |
Primary outcome
wound size
Time frame: after 1week post operative
by centimeters
wound infection
Time frame: during 1week post operative
which degree of infection or if there is a burst wound
hospital stay
Time frame: 1week post operative
by days post operative
air leak duration
Time frame: during 1week post operative
by days and takes how many days to stop air leakage
pain score
Time frame: during 1week post operative.
through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)
Early mobilization.
Time frame: during 1week post operative
how many days
3 secondary outcomes
chronic pain
Time frame: after 1month post operative
avoidance of scoliosis
Time frame: after 1month post operative
shoulder muscle girdle weakness and deformity.
Time frame: after 1month post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 33334937Arnold DT, Hamilton FW, Morris TT, Suri T, Morley A, Frost V, Vipond IB, Medford AR, Payne RA, Muir P, Maskell NA. Epidemiology of pleural empyema in English hospitals and the impact of influenza. Eur Respir J. 2021 Jun 17;57(6):2003546. doi: 10.1183/13993003.03546-2020. Print 2021 Jun.
- Background: PubMed 26919911Krenke K, Urbankowska E, Urbankowski T, Lange J, Kulus M. Clinical characteristics of 323 children with parapneumonic pleural effusion and pleural empyema due to community acquired pneumonia. J Infect Chemother. 2016 May;22(5):292-7. doi: 10.1016/j.jiac.2016.01.016. Epub 2016 Feb 23.
- Background: PubMed 26807282Shojaee S, Lee HJ. Thoracoscopy: medical versus surgical-in the management of pleural diseases. J Thorac Dis. 2015 Dec;7(Suppl 4):S339-51. doi: 10.3978/j.issn.2072-1439.2015.11.66.
- Background: PubMed 30707629Bedawi EO, Hassan M, McCracken D, Rahman NM. Pleural infection: a closer look at the etiopathogenesis, microbiology and role of antibiotics. Expert Rev Respir Med. 2019 Apr;13(4):337-347. doi: 10.1080/17476348.2019.1578212. Epub 2019 Feb 20.
- Individual participant dataSharing planned: No
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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.
Mohamed Ayyad, prof. study director
professor
Mahmoud sallam, MD study director
doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video assisted thoracoscopy (VATS) and open thoracotomy in people with Thoracic Empyema, run by Assiut University at 1 site in Egypt.
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 9 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 ali zein eladein, Ass.Lect. (+201014566896, ali_zein@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound size (time frame: after 1week post operative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424457, which also lists 4 linked publications.
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 23 May 2024.