Complicated Infections in Otorhinolaryngology (ENT_infect)

University Medical Centre Ljubljana

Status: Enrolling

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

Treatments: Other: Treatment with surgery and/or conservative measures

Study type: Observational

Funder types: Other

Identifiers

NCT06023550

ENT infections

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,550 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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,
• failure to meet the inclusion criteria.

Trial design

2,550 participants in 4 patient groups

Complicated sinonasal infection

Description:

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

Treatment:

Other: Treatment with surgery and/or conservative measures

Complicated ear or temporal bone infection

Description:

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

Treatment:

Other: Treatment with surgery and/or conservative measures

Complicated neck soft tissue infection

Description:

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

Treatment:

Other: Treatment with surgery and/or conservative measures

Complicated laryngeal infection

Description:

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

Treatment:

Other: Treatment with surgery and/or conservative measures