NCT06041074

Brief Summary

In this observational cross-sectional study " the clinical characteristics of adenoid vegetations in adulthood will be investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 9, 2024

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 5, 2023

Last Update Submit

April 6, 2024

Conditions

Adenoid Vegetation

Outcome Measures

Primary Outcomes (1)

  • Symptoms

    The leading symptom (patient's main complaint, the reason for seeing the doctor) will we recorded for each participant

    2 months

Secondary Outcomes (10)

  • Duration of symptoms

    2 months

  • OTS (otoscopic)

    2 months

  • RNS (rhinoscopic)

    2 months

  • OFS (oropharyngoscopic)

    2 months

  • PRNS (post-rhynoscopic)

    2 months

  • +5 more secondary outcomes

Study Arms (2)

Adults

Patients with adenoid vegetations, 14 years old and older

Children

Patients with adenoid vegetations, 13 years old and younger

Eligibility Criteria

Age1 Year - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult group: All patients aged 14 and more treated for adenoid vegetations in Varazdin General Hospital from 1 January 2013 to 31 December 2019 Children group: All patients aged 13 and less treated for adenoid vegetations in Varazdin General Hospital from 1 January 2019 to 31 December 2019

You may qualify if:

  • patient with adenoid vegetations

You may not qualify if:

  • other concomitant otorhinolaryngological diagnoses
  • hypertrophy of the tonsils
  • oropharyngeal carcinomas
  • chronic sinuitis
  • allergic rhinitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Varazdin General Hospital

Varaždin, 42000, Croatia

Location

Study Officials

  • Drazen Shejbal

    Varazdin General Hospital, Varazdin, Croatia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 18, 2023

Study Start

September 15, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 9, 2024

Record last verified: 2023-09

Locations

CR(1)