Thoracoscopy for Idiopathic Pneumothorax in Children

Child, Only Clinical Trial

— PNOPED  

Official title:

Video-Assisted Thoracoscopy for Idiopathic Pneumothorax in Children: a Retrospective Monocentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861037
• Other study ID #: ULothop
• Secondary ID: 2023PI009
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: University of Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 diminishing the recurrence of pneumothorax?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Pneumothorax
• Spontaneous Pneumothorax

Intervention

Other:
• Video-Assisted Thoracoscopy with blebectomy and pleural abrasion
Thoracoscopic management of pneumothorax

Locations

Country	Name	City	State
France	ULorraine	Vandœuvre-lès-Nancy	Grand-Est

Sponsors (1)

Lead Sponsor	Collaborator
University of Lorraine

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of pneumothorax	Recurrence of pneumothorax after first pleural drainage or persistant air leaking	Through study completion, an average of 2 years
Secondary	Other complications after surgery	Hemothorax, early and late recurrence	Through study completion, an average of 2 years
Secondary	Operating Time	Time for surgery	Intraoperative
Secondary	Length of stay	Length of stay	From admission to discharge home, up to 20 days
Secondary	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.	Through study completion, an average of 2 years