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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05861037
Other study ID # ULothop
Secondary ID 2023PI009
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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