Pulmonary AspergillosisNCT06564727
Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience
A study testing Uniportal VATS approach and VATS approach in people with Pulmonary Aspergillosis and Surgery-Complications, run by Hassan II University at 1 site in Morocco.
Trial summary
The objective of this study was to report our experience with U-VATS resection and to evaluate our surgical outcomes with an analysis of postoperative complications. The investigators also estimate the prognostic factors that influence the morbidity and the conversion. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Aspergillosis, Surgery-Complications, Thoracic Diseases
- What is being tested?
- Uniportal VATS approach and VATS approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jan 2017to 30 Jan 2020
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Treatment using uniportal VATS
Who cannot join
- Resection using thoracotomy
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to report our experience with U-VATS resection and to evaluate our surgical outcomes with an analysis of postoperative complications. The investigators also estimate the prognostic factors that influence the morbidity and the conversion.
Read the detailed description
Evaluation of prognostic factors Tuberculosis Hemoptysis Type of aspergilloma presence of complete adherence Procedure
- Being tested
- Uniportal VATS approach, VATS approach
- Medical subject headings
- Pulmonary Aspergillosis, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uniportal VATS approachProcedure or surgery
Uniportal VATS resection for simple pulmonary aspergilloma
VATS approachProcedure or surgery
VATS resection for complex pulmonary aspergilloma
| Study group | Role | What they receive |
|---|---|---|
| Uniportal VATS approach | Experimental | patient treated by Uniportal VATS technique Receives: Procedure: Uniportal VATS approach |
| VATS resection | Active comparator | patients treated by VATS technique Receives: Procedure: VATS approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
evaluate the complication at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AspergillosisStudies of the same condition, open and under way.
- 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
- Model description
- study the effect of a treatment and evaluate outcome postoperatively
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hassan II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara WAGUAF, Hassan II University
- Investigators
- sara WAGUAF, Principal investigator, Hassan II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564727
- Sponsor's protocol ID
- pulmonary aspergilloma
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience
- ClinicalTrials.gov ID
- NCT06564727
- Acronym / sponsor ID
- pulmonary aspergilloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hassan II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 21 Aug 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 objective of this study was to report our experience with U-VATS resection and to evaluate our surgical outcomes with an analysis of postoperative complications. The investigators also estimate the prognostic factors that influence the morbidity and the conversion.
Detailed description
Evaluation of prognostic factors Tuberculosis Hemoptysis Type of aspergilloma presence of complete adherence Procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- study the effect of a treatment and evaluate outcome postoperatively
| Arm | Type | Receives |
|---|---|---|
| Uniportal VATS approach | Experimental | Procedure: Uniportal VATS approachpatient treated by Uniportal VATS technique |
| VATS resection | Active comparator | Procedure: VATS approachpatients treated by VATS technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Treatment using uniportal VATS
Key exclusion criteria (1 listed)
- Resection using thoracotomy
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 |
|---|---|---|
| Uniportal VATS approachUniportal VATS resection for simple pulmonary aspergilloma | Procedure or surgery | Uniportal VATS approach |
| VATS approachVATS resection for complex pulmonary aspergilloma | Procedure or surgery | VATS resection |
Primary outcome
postoperative complications
Time frame: 30 days
evaluate the complication at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
sara WAGUAF principal investigator
Hassan II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uniportal VATS approach and VATS approach in people with Pulmonary Aspergillosis and Surgery-Complications, run by Hassan II University at 1 site in Morocco.
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: finished, as of the sponsor's last update on 21 Aug 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 Morocco. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative complications (time frame: 30 days). 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 21 Aug 2024.