Lung Herniation After Uniportal VATS | NCT04566094

Studies
Lung Herniation After Uniportal VATS

NCT04566094

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Withdrawn

Last Update Posted

Mar 30, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Lung Hernia
Thoracoscopy
Postoperative

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PIs moved to other department

Expanded Access Info

Start Date

Nov 1, 2025Estimated

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Sep 22, 2020

First Submission Date that Met QC Criteria

Sep 22, 2020

First Posted Date

Sep 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2025

Last Update Posted Date

Mar 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung herniation	Presence of intercostal lung herniation after uniportal VATS	Postoperative follow-up up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Symptoms	Symptoms described by patients presenting an intercostal lung hernia	Postoperative follow-up to 5 years
Risk factors	Presence of Risk factors associated with the development of intercostal lung hernia after uniportal VATS surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anatomical lung resection using uniportal VATS

Exclusion Criteria:

Non anatomical lung resection
Open surgery
Pneumonectomy
Informed consent not signed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jon Lutz, MD	Department of General Thoracic Surgery Bern University Hospital	Principal Investigator

Locations

Not provided