Spontaneous PneumothoraxTHOPEDNCT06734442
Thoracoscopy for Idiopathic Pneumothorax in Children
An observational study of Spontaneous Pneumothorax and Idiopathic Pneumothorax, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The goal of this retrospective study is to describe the outcomes of spontaneous idiopathic pneumothorax treated by thoracoscopy with pleural abrasion and blebectomy. The main questions it aims to answer are: are there risk factors leading to pneumothorax recurrence? are pleural abrasion and blebectomy really… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Spontaneous Pneumothorax, Idiopathic Pneumothorax, Bleb Lung
- What is being tested?
- Video-Assisted Thoracoscopy with blebectomy and pleural abrasion
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2022to 31 Dec 2022
- Phase
- Observational
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients who were operated from 2014 to 2022
Who may be able to join
- Patients younger than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax
Who cannot join
- Patients older than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
About this study
Official title: Surgical Management of Primary Spontaneous Pneumothorax in Children
The goal of this retrospective study is to describe the outcomes of spontaneous idiopathic pneumothorax treated by thoracoscopy with pleural abrasion and blebectomy.
The main questions it aims to answer are:
- are there risk factors leading to pneumothorax recurrence?
- are pleural abrasion and blebectomy really diminishing the recurrence of pneumothorax?
Read the detailed description
The investigators describe the outcomes of the participants: length of stay, operating time, type and time before recurrence, occurrence of contralateral pneumothorax also treated by thoracoscopy, with pleural abrasion and blebectomy
- Being tested
- Video-Assisted Thoracoscopy with blebectomy and pleural abrasion
- Keywords
- Video-Assisted Thoracoscopy, Spontaneous Idiopathic Pneumothorax, Blebectomy, Lung Wedge, Pleural Abrasion, Retrospective Study, Child
- Medical subject headings
- Pneumothorax, Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Thoracoscopy with blebectomy and pleural abrasionOther
Thoracoscopic management of pneumothorax
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pneumothorax
- Recurrence of pneumothorax Recurrence of pneumothorax after first pleural drainage or persistant air leaking
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
Other complications after surgery
Hemothorax, early and late recurrence
Measured: Through study completion, an average of 2 years
Operating Time
Time for surgery
Measured: Intraoperative
Length of stay
Length of stay
Measured: From admission to discharge home, up to 20 days
The time between the surgery and postoperative consultation dates
Follow-up represents the time between the surgery and postoperative consultation dates in days, months, or years.
Generally, there are a-month-follow-up, a three month-follow-up, a six month-follow-up, and a year-follow-up. The surgeon can see the patient if there is any problem between these consultations. After a year of follow-up, it is up to the surgeon to decide if the patient needs to be seen yearly or not. The last follow-up date is crucial because it indicates how the patient is and if other follow-up dates need to be applied.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Nov 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spontaneous PneumothoraxStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Responsible party
- Principal investigator, Destinval Christelle, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734442
- Sponsor's protocol ID
- M24DC1106
- Acronym
- THOPED
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the name of anonymization the investigators won't share individual participant data
Publications
Demir M, Akin M, Kaba M, Filiz S, Sever N, Karadag CA, Dokucu AI. Thoracoscopic Resection in the Treatment of Spontaneous Pneumothorax. Sisli Etfal Hastan Tip Bul. 2020 Mar 25;54(1):94-97. doi: 10.14744/SEMB.2018.88310. eCollection 2020.
PubMed 32377141Pogorelic Z, Gudelj R, Bjelanovic D, Jukic M, Elezovic Baloevic S, Glumac S, Furlan D. Management of the Pediatric Spontaneous Pneumothorax: The Role of Video-Assisted Thoracoscopic Surgery. J Laparoendosc Adv Surg Tech A. 2020 May;30(5):569-575. doi: 10.1089/lap.2019.0742. Epub 2020 Mar 11.
PubMed 32167851
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Primary Spontaneous Pneumothorax in Children
- ClinicalTrials.gov ID
- NCT06734442
- Acronym / sponsor ID
- THOPED / M24DC1106
- Keywords
- Video-Assisted Thoracoscopy, Spontaneous Idiopathic Pneumothorax, Blebectomy, Lung Wedge, Pleural Abrasion, Retrospective Study, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Dec 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 retrospective study is to describe the outcomes of spontaneous idiopathic pneumothorax treated by thoracoscopy with pleural abrasion and blebectomy.
The main questions it aims to answer are:
- are there risk factors leading to pneumothorax recurrence?
- are pleural abrasion and blebectomy really diminishing the recurrence of pneumothorax?
Detailed description
The investigators describe the outcomes of the participants: length of stay, operating time, type and time before recurrence, occurrence of contralateral pneumothorax also treated by thoracoscopy, with pleural abrasion and blebectomy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who were operated from 2014 to 2022
Key inclusion criteria (1 listed)
- Patients younger than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax
Key exclusion criteria (1 listed)
- Patients older than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax
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 with blebectomy and pleural abrasionThoracoscopic management of pneumothorax | Other | – |
Primary outcome
Recurrence of pneumothorax
Time frame: Through study completion, an average of 2 years
1. Recurrence of pneumothorax Recurrence of pneumothorax after first pleural drainage or persistant air leaking
4 secondary outcomes
Other complications after surgery
Time frame: Through study completion, an average of 2 years
Operating Time
Time frame: Intraoperative
Length of stay
Time frame: From admission to discharge home, up to 20 days
The time between the surgery and postoperative consultation dates
Time frame: Through study completion, an average of 2 years
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 16 Dec 2024.
- Background: PubMed 32377141Demir M, Akin M, Kaba M, Filiz S, Sever N, Karadag CA, Dokucu AI. Thoracoscopic Resection in the Treatment of Spontaneous Pneumothorax. Sisli Etfal Hastan Tip Bul. 2020 Mar 25;54(1):94-97. doi: 10.14744/SEMB.2018.88310. eCollection 2020.
- Background: PubMed 32167851Pogorelic Z, Gudelj R, Bjelanovic D, Jukic M, Elezovic Baloevic S, Glumac S, Furlan D. Management of the Pediatric Spontaneous Pneumothorax: The Role of Video-Assisted Thoracoscopic Surgery. J Laparoendosc Adv Surg Tech A. 2020 May;30(5):569-575. doi: 10.1089/lap.2019.0742. Epub 2020 Mar 11.
- Individual participant dataSharing planned: No. In the name of anonymization the investigators won't share individual participant data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Pneumothorax and Idiopathic Pneumothorax, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 16 Dec 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 France. 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?
Recurrence of pneumothorax (time frame: Through study completion, an average of 2 years). 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 NCT06734442, which also lists 2 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 16 Dec 2024.