- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05861037
Thoracoscopy for Idiopathic Pneumothorax in Children (PNOPED)
May 15, 2023 updated by: Dr Christelle DESTINVAL, University of Lorraine
Video-Assisted Thoracoscopy for Idiopathic Pneumothorax in Children: a Retrospective Monocentric Study
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?
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
23
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Grand-Est
-
Vandœuvre-lès-Nancy, Grand-Est, France, 54500
- ULorraine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who were operated in our service from 2014 to 2022
Description
Inclusion Criteria:
- Patients younger than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax
Exclusion Criteria:
- Patients older than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of pneumothorax
Time Frame: Through study completion, an average of 2 years
|
Recurrence of pneumothorax after first pleural drainage or persistant air leaking
|
Through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other complications after surgery
Time Frame: Through study completion, an average of 2 years
|
Hemothorax, early and late recurrence
|
Through study completion, an average of 2 years
|
Operating Time
Time Frame: Intraoperative
|
Time for surgery
|
Intraoperative
|
Length of stay
Time Frame: From admission to discharge home, up to 20 days
|
Length of stay
|
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
|
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.
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christelle Destinval, MD, University of Lorraine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pogorelic 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
March 31, 2023
Study Registration Dates
First Submitted
April 13, 2023
First Submitted That Met QC Criteria
May 15, 2023
First Posted (Actual)
May 16, 2023
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULothop
- 2023PI009 (Registry Identifier: DRCI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
In the name of anonymization the investigators won't share individual participant data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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