Clinical trial NCT06023550: Complicated Infections in Otorhinolaryngology
Official title: Analysis of Complicated Infections in Pediatric and Adult Populations Treated by Otorhinolaryngologist
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sinusitis
Otitis
Laryngitis
Lymphadenitis
Quinsy
Peritonsillar Abscess
Parapharyngeal Abscess
Preseptal Cellulitis
Subperiosteal Abscess
Orbital Abscess
Epiglottitis
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 2550
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complicated infections treated by otorhinolaryngologists in the tertiary otorhinolaryngology referral centre.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Department of Otorhinolaryngology and Cervicofacial Surgery, UMC Ljubljana
name: Domen Vozel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: