Complicated Infections in Otorhinolaryngology

NCT ID: NCT06023550

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2028-09-30

Brief Summary

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This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are:

* What is the management of complicated sinonasal infections in Ljubljana, Slovenia,
* What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia,
* What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia,
* What is the management of complicated laryngeal infections in Ljubljana, Slovenia

Participants will receive standard treatment according to the established evidence-based clinical practice.

Detailed Description

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The main purpose of the research is to obtain own data on the treatment of patients with infections in ENT areas that require targeted treatment by an otolaryngologist at the hospital level. Based on these results, treatment outcome would be improved and hospitalization time would be shortened. We would establish clinical pathways for the treatment of these diseases in Slovenia. There is still no data on the treatment of these diseases in ENT departments in Slovenia, so one of the main purposes of the research is to obtain objective indicators of the success of treatment in comparison with other countries and a rough epidemiological assessment of the disease in Slovenia.

The research would establish a database of patients with complicated infections in ENT areas at the University Clinical Center Ljubljana, which would be used for prospective analysis even after the research was completed. The register would also enable transparency in the treatment of these patients in the future.

The main questions to answer are:

* What is the management of complicated sinonasal infections in Ljubljana, Slovenia,
* What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia,
* What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia,
* What is the management of complicated laryngeal infections in Ljubljana, Slovenia

Participants will receive standard treatment according to the established evidence-based clinical practice.

Conditions

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Sinusitis Otitis Laryngitis Lymphadenitis Quinsy Peritonsillar Abscess Parapharyngeal Abscess Preseptal Cellulitis Subperiosteal Abscess Orbital Abscess Epiglottitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Complicated sinonasal infection

Group of patients with a complicated sinonasal infection, including local or systemic complications.

Treatment with surgery and/or conservative measures

Intervention Type OTHER

Patients will be treated according to established clinical practice with surgery and/or conservative measures.

Complicated ear or temporal bone infection

Group of patients with a complicated ear or temporal bone infection, including local or systemic complications.

Treatment with surgery and/or conservative measures

Intervention Type OTHER

Patients will be treated according to established clinical practice with surgery and/or conservative measures.

Complicated neck soft tissue infection

Group of patients with a complicated neck soft tissue infection, including local or systemic complications.

Treatment with surgery and/or conservative measures

Intervention Type OTHER

Patients will be treated according to established clinical practice with surgery and/or conservative measures.

Complicated laryngeal infection

Group of patients with a complicated laryngeal infection, including local or systemic complications.

Treatment with surgery and/or conservative measures

Intervention Type OTHER

Patients will be treated according to established clinical practice with surgery and/or conservative measures.

Interventions

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Treatment with surgery and/or conservative measures

Patients will be treated according to established clinical practice with surgery and/or conservative measures.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnoses: rhinitis AND/OR sinusitis AND/OR facial cellulitis AND/OR facial abscess AND/OR nasal furuncle AND/OR infection of the outer AND/OR middle AND/OR inner ear AND/OR temporal bone AND/OR infection of the soft tissues of the neck with/without bone and cartilage involvement AND/OR laryngitis AND/OR epiglottitis (or supraglottitis) AND/OR
* complication of inflammation of the nose and paranasal cavities AND/OR ear AND/OR temporal bone AND/OR:
* treated at the Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Center Ljubljana.

Exclusion Criteria

* disagreement of the patient and/or parents (or legal guardians) with inclusion in the research,
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Domen Vozel, MD, PhD

Domen Vozel, MD, PhD, ENT specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Domen Vozel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana

Locations

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University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Domen Vozel, MD, PhD

Role: CONTACT

+38615223280

Facility Contacts

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Domen Vozel, MD, PhD

Role: primary

Other Identifiers

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ENT infections

Identifier Type: -

Identifier Source: org_study_id

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