Pulmonary Hydatid CystVATSNCT04412512
VATS Versus Thoracotomy for Pulmonary Hydatid Disease
A study testing VATS approach and Thoracotomy approach in people with Pulmonary Hydatid Cyst, run by Hassan II University at 1 site in Morocco.
Trial summary
The aim of this study is to evaluate the efficacy and safety of minimally invasive surgery and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary Hydatid Cyst. Disease : pulmonary hydatid cyst. Intervention: Group 1 : VATS approach. Group 2 : thoracotomy approach. Read more about this study
- Who is it for?
- Ages 6 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hydatid Cyst
- What is being tested?
- VATS approach and Thoracotomy approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteMorocco
- Study dates
- Jan 2016to Apr 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 6 to 81 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients underwent surgery for pulmonary hydatid cyst
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the efficacy and safety of minimally invasive surgery and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary Hydatid Cyst.
Disease : pulmonary hydatid cyst.
Intervention:
- Group 1 : VATS approach.
- Group 2 : thoracotomy approach.
Read the detailed description
After being informed about the study and the approach, all patients giving written informed consent to determine eligibility for study entry.
- Conditions
- Pulmonary Hydatid Cyst
- Being tested
- VATS approach, Thoracotomy approach
- Keywords
- pulmonary hydatid cyst, video-assisted thoracic surgery, thoracotomy
- Medical subject headings
- Echinococcosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS approachProcedure or surgery
video-assisted thoracic surgery approach
Thoracotomy approachProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| VATS approach | Experimental | patients treated by VATS technique. Receives: Procedure: VATS approach |
| Thoracotomy approach | Active comparator | patients treated by Thoracotomy technique Receives: Procedure: Thoracotomy 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 posted2 Jun 2020
- Study startJan 2016
- Primary completionDec 2019
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hydatid CystStudies 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 postoperative
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 134 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
- NCT04412512
- Sponsor's protocol ID
- VATS for pulmonary hydatid
- Acronym
- VATS
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VATS Versus Thoracotomy for Pulmonary Hydatid Disease
- ClinicalTrials.gov ID
- NCT04412512
- Acronym / sponsor ID
- VATS / VATS for pulmonary hydatid
- Conditions
- Pulmonary Hydatid Cyst
- Keywords
- pulmonary hydatid cyst, video-assisted thoracic surgery, thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Hassan II UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 2 Jun 2020 (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 aim of this study is to evaluate the efficacy and safety of minimally invasive surgery and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary Hydatid Cyst.
Disease : pulmonary hydatid cyst.
Intervention:
- Group 1 : VATS approach.
- Group 2 : thoracotomy approach.
Detailed description
After being informed about the study and the approach, all patients giving written informed consent to determine eligibility for study entry.
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 postoperative
| Arm | Type | Receives |
|---|---|---|
| VATS approach | Experimental | Procedure: VATS approachpatients treated by VATS technique. |
| Thoracotomy approach | Active comparator | Procedure: Thoracotomy approachpatients treated by Thoracotomy technique |
Who may qualify
- Ages
- 6 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients underwent surgery for pulmonary hydatid cyst
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| VATS approachvideo-assisted thoracic surgery approach | Procedure or surgery | VATS approach |
| Thoracotomy approach | Procedure or surgery | Thoracotomy approach |
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 2 Jun 2020.
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 VATS approach and Thoracotomy approach in people with Pulmonary Hydatid Cyst, 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 2 Jun 2020. 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 2 Jun 2020.