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NCT04566094 Clinical Trial

Lung Herniation After Uniportal VATS

Postoperative Clinical Trial

Official title:
Lung Herniation After Uniportal VATS. Rarity or Common Finding?

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04566094
Other study ID # 17092020
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date December 2021

Study information
Verified date September 2020
Source University Hospital Inselspital, Berne
Contact Filipe Azenha, MD
Phone 0041 31 632 37 45
Email luis.azenha@insel.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 425
Est. completion date December 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Anatomical lung resection using uniportal VATS

Exclusion Criteria:

- Non anatomical lung resection

- Open surgery

- Pneumonectomy

- Informed consent not signed

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Bern University Hospital Bern

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lung herniation Presence of intercostal lung herniation after uniportal VATS Postoperative follow-up up to 6 months
Secondary Symptoms Symptoms described by patients presenting an intercostal lung hernia Postoperative follow-up to 5 years
Secondary Risk factors Presence of Risk factors associated with the development of intercostal lung hernia after uniportal VATS surgery At the time of operation
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