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Lung Herniation After Uniportal VATS

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04566094
Collaborator
(none)
425
Enrollment
1
Location
13
Anticipated Duration (Months)
32.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

During patient follow up the investigators noticed the occasional occurence of a lung herniation after uniportal Video assisted thoracoscopic surgery (VATS). Most of These patients were asymptomatic and didn't require any kind of treatment. To analyse the incidence of postoperative lung herniation after uniportal and the presence of symptoms the investigators decided to review every postoperative CT scan from January 2016 until March 2019 to radiologically identify postoperative lung herniations. Afterwards the investigators will contact the respective patient to ask for a follow-up physical examination and symptom evaluation (after consent was signed).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    425 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Lung Herniation After Uniportal VATS. Rarity or Common Finding?
    Anticipated Study Start Date :
    Nov 1, 2020
    Anticipated Primary Completion Date :
    Nov 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Lung herniation [Postoperative follow-up up to 6 months]

      Presence of intercostal lung herniation after uniportal VATS

    Secondary Outcome Measures

    1. Symptoms [Postoperative follow-up to 5 years]

      Symptoms described by patients presenting an intercostal lung hernia

    2. Risk factors [At the time of operation]

      Presence of Risk factors associated with the development of intercostal lung hernia after uniportal VATS surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Anatomical lung resection using uniportal VATS
    Exclusion Criteria:

    • Non anatomical lung resection

    • Open surgery

    • Pneumonectomy

    • Informed consent not signed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bern University Hospital Bern Switzerland 3007

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

    • Principal Investigator: Jon Lutz, MD, Department of General Thoracic Surgery Bern University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT04566094
    Other Study ID Numbers:
    • 17092020
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    Sep 28, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hernia

    Study Results

    No Results Posted as of Sep 28, 2020