PNOPED: Thoracoscopy for Idiopathic Pneumothorax in Children

Sponsor
University of Lorraine (Other)
Overall Status
Completed
CT.gov ID
NCT05861037
Collaborator
(none)
23
1
4.9
4.7

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: Video-Assisted Thoracoscopy with blebectomy and pleural abrasion

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

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Video-Assisted Thoracoscopy for Idiopathic Pneumothorax in Children: a Retrospective Monocentric Study
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
Dec 31, 2022
Actual Study Completion Date :
Mar 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Recurrence of pneumothorax [Through study completion, an average of 2 years]

    Recurrence of pneumothorax after first pleural drainage or persistant air leaking

Secondary Outcome Measures

  1. Other complications after surgery [Through study completion, an average of 2 years]

    Hemothorax, early and late recurrence

  2. Operating Time [Intraoperative]

    Time for surgery

  3. Length of stay [From admission to discharge home, up to 20 days]

    Length of stay

  4. The time between the surgery and postoperative consultation dates [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ULorraine Vandœuvre-lès-Nancy Grand-Est France 54500

Sponsors and Collaborators

  • University of Lorraine

Investigators

  • Principal Investigator: Christelle Destinval, MD, University of Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine
ClinicalTrials.gov Identifier:
NCT05861037
Other Study ID Numbers:
  • ULothop
  • 2023PI009
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2023