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Lung Herniation After Uniportal VATS

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ClinicalTrials.gov Identifier: NCT04566094
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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
Lung Hernia Thoracoscopy Postoperative

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Lung herniation [ Time Frame: Postoperative follow-up up to 6 months ]
    Presence of intercostal lung herniation after uniportal VATS


Secondary Outcome Measures :
  1. Symptoms [ Time Frame: Postoperative follow-up to 5 years ]
    Symptoms described by patients presenting an intercostal lung hernia

  2. Risk factors [ Time Frame: At the time of operation ]
    Presence of Risk factors associated with the development of intercostal lung hernia after uniportal VATS surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every patient submitted to uniportal VATS anatomic lung resection from January 2016 until March 2019 who has had a postoperative radiological follow up.
Criteria

Inclusion Criteria:

  • Anatomical lung resection using uniportal VATS

Exclusion Criteria:

  • Non anatomical lung resection
  • Open surgery
  • Pneumonectomy
  • Informed consent not signed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566094


Contacts
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Contact: Filipe Azenha, MD 0041 31 632 37 45 ext 0041316322330 luis.azenha@insel.ch
Contact: Jon Lutz, MD 0041 31 632 23 30 ext 0041316322330 jon.lutz@insel.ch

Locations
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Switzerland
Bern University Hospital
Bern, Switzerland, 3007
Contact: Luís Filipe Azenha Figueiredo, MD    0041 31 632 37 45    luis.azenha@gmail.com   
Contact: Jon Lutz, MD    0041 31 632 23 30    jon.lutz@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Jon Lutz, MD Department of General Thoracic Surgery Bern University Hospital
More Information
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04566094    
Other Study ID Numbers: 17092020
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical