Lung Herniation After Uniportal VATS

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).

Study Overview

• Status: Unknown
• Conditions: Thoracoscopy; Postoperative; Lung Hernia

• Study Type: Observational
• Enrollment (Anticipated): 425

Contacts and Locations

• Study Contact: Name: Filipe Azenha, MD; Phone Number: 0041316322330 0041 31 632 37 45; Email: luis.azenha@insel.ch
• Study Contact Backup: Name: Jon Lutz, MD; Phone Number: 0041316322330 0041 31 632 23 30; Email: jon.lutz@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3007
    • Bern University Hospital
    • Contact: Luís Filipe Azenha Figueiredo, MD; Phone Number: 0041 31 632 37 45; Email: luis.azenha@gmail.com
    • Contact: Jon Lutz, MD; Phone Number: 0041 31 632 23 30; Email: jon.lutz@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Anatomical lung resection using uniportal VATS

Exclusion Criteria:

• Non anatomical lung resection
• Open surgery
• Pneumonectomy
• Informed consent not signed

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	At the time of operation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 17092020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No