NCT06734442

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 11, 2024

Last Update Submit

December 11, 2024

Conditions

Keywords

Video-Assisted ThoracoscopySpontaneous Idiopathic PneumothoraxBlebectomyLung WedgePleural AbrasionRetrospective StudyChild

Outcome Measures

Primary Outcomes (1)

  • Recurrence of pneumothorax

    1\. Recurrence of pneumothorax Recurrence of pneumothorax after first pleural drainage or persistant air leaking

    Through study completion, an average of 2 years

Secondary Outcomes (4)

  • Other complications after surgery

    Through study completion, an average of 2 years

  • Operating Time

    Intraoperative

  • Length of stay

    From admission to discharge home, up to 20 days

  • The time between the surgery and postoperative consultation dates

    Through study completion, an average of 2 years

Interventions

Thoracoscopic management of pneumothorax

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients who were operated from 2014 to 2022

You may qualify if:

  • Patients younger than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax

You may not qualify if:

  • Patients older than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related 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.

    PMID: 32377141BACKGROUND
  • 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.

    PMID: 32167851BACKGROUND

MeSH Terms

Conditions

PneumothoraxBlister

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesSkin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 16, 2024

Study Start

November 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

In the name of anonymization the investigators won't share individual participant data

Locations