Lung HerniaNCT04566094
Lung Herniation After Uniportal VATS
An observational study of Lung Hernia and Thoracoscopy, run by Insel Gruppe AG, University Hospital Bern.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Hernia, Thoracoscopy, Postoperative
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Anatomical lung resection using uniportal VATS
Who cannot join
- Non anatomical lung resection
- Open surgery
- Pneumonectomy
- Informed consent not signed
About this study
Official title: Lung Herniation After Uniportal VATS. Rarity or Common Finding?
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).
- Conditions
- Lung Hernia, Thoracoscopy, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung herniation
Presence of intercostal lung herniation after uniportal VATS
Measured: Postoperative follow-up up to 6 months
Secondary outcomes (2)
Symptoms
Symptoms described by patients presenting an intercostal lung hernia
Measured: Postoperative follow-up to 5 years
Risk factors
Presence of Risk factors associated with the development of intercostal lung hernia after uniportal VATS surgery
Measured: At the time of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: PIs moved to other department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung HerniaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Lutz, MD, Principal investigator, Department of General Thoracic Surgery Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566094
- Sponsor's protocol ID
- 17092020
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Herniation After Uniportal VATS. Rarity or Common Finding?
- ClinicalTrials.gov ID
- NCT04566094
- Acronym / sponsor ID
- 17092020
- Conditions
- Lung Hernia, Thoracoscopy, Postoperative
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PIs moved to other department
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Anatomical lung resection using uniportal VATS
Key exclusion criteria (4 listed)
- Non anatomical lung resection
- Open surgery
- Pneumonectomy
- Informed consent not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung herniation
Time frame: Postoperative follow-up up to 6 months
Presence of intercostal lung herniation after uniportal VATS
2 secondary outcomes
Symptoms
Time frame: Postoperative follow-up to 5 years
Risk factors
Time frame: At the time of operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Lutz, MD principal investigator
Department of General Thoracic Surgery Bern University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Hernia and Thoracoscopy, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung herniation (time frame: Postoperative follow-up up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.