Adenoid VegetationNCT06041074
Adenoid Vegetations in Adult Patients
An observational study of Adenoid Vegetation, run by Varazdin General Hospital at 1 site in Croatia.
Trial summary
In this observational cross-sectional study " the clinical characteristics of adenoid vegetations in adulthood will be investigated. Read more about this study
- Who is it for?
- Ages 1 year to 105 years
- Conditions the study is for
- Adenoid Vegetation
- How many people
- 161 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Sep 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 105 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- patient with adenoid vegetations
Who cannot join
- other concomitant otorhinolaryngological diagnoses
- hypertrophy of the tonsils
- oropharyngeal carcinomas
- chronic sinuitis
- allergic rhinitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Characteristics of Adenoid Vegetations in Adult Patients
In this observational cross-sectional study " the clinical characteristics of adenoid vegetations in adulthood will be investigated.
Read the detailed description
Adenoid vegetations typically appear in childhood and are well described in this population. However, in adulthood, adenoid vegetations appear rarely and their characteristics have not been described.
The clinical characteristics of adenoid vegetations in adulthood will be investigated, and compared with clinical characteristics of adenoid vegetations in childhood.
- Conditions
- Adenoid Vegetation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults | Patients with adenoid vegetations, 14 years old and older | |
| Children | Patients with adenoid vegetations, 13 years old and younger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms
The leading symptom (patient's main complaint, the reason for seeing the doctor) will we recorded for each participant
Measured: 2 months
Secondary outcomes (10)
Duration of symptoms
The duration of leading symptom (in months) will be recorded for each participant
Measured: 2 months
OTS (otoscopic)
The otoscopic findings will be recorded in both groups
Measured: 2 months
RNS (rhinoscopic)
The rhinoscopic findings will be recorded in both groups
Measured: 2 months
OFS (oropharyngoscopic)
The oropharyngoscopic findings will be recorded in both groups
Measured: 2 months
PRNS (post-rhynoscopic)
The post-rhynoscopic findings will be recorded in both groups
Measured: 2 months
Referring physician
The physician (primary or secondary level) who referred the patient to ENT (Ear Nose and Throat doctor) will be recorded in both groups
Measured: 2 months
PHD ( pathohistological findings)
The pathohistological findings will be recorded in both groups
Measured: 2 months
Surgery
The type of surgery will be recorded in both groups
Measured: 2 months
Outcome
The outcome (the relief of the leading symptom) will be recorded in both groups
Measured: 2 months
Recurrence
The recurrence will be recorded in both groups
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start15 Sep 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid VegetationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varazdin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drazen Shejbal, Principal investigator, Varazdin General Hospital, Varazdin, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041074
- Sponsor's protocol ID
- 1968
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Characteristics of Adenoid Vegetations in Adult Patients
- ClinicalTrials.gov ID
- NCT06041074
- Acronym / sponsor ID
- 1968
- Conditions
- Adenoid Vegetation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Varazdin General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this observational cross-sectional study " the clinical characteristics of adenoid vegetations in adulthood will be investigated.
Detailed description
Adenoid vegetations typically appear in childhood and are well described in this population. However, in adulthood, adenoid vegetations appear rarely and their characteristics have not been described.
The clinical characteristics of adenoid vegetations in adulthood will be investigated, and compared with clinical characteristics of adenoid vegetations in childhood.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | –Patients with adenoid vegetations, 14 years old and older |
| Children | – | –Patients with adenoid vegetations, 13 years old and younger |
Who may qualify
- Ages
- 1 year to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patient with adenoid vegetations
Key exclusion criteria (5 listed)
- other concomitant otorhinolaryngological diagnoses
- hypertrophy of the tonsils
- oropharyngeal carcinomas
- chronic sinuitis
- allergic rhinitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptoms
Time frame: 2 months
The leading symptom (patient's main complaint, the reason for seeing the doctor) will we recorded for each participant
10 secondary outcomes
Duration of symptoms
Time frame: 2 months
OTS (otoscopic)
Time frame: 2 months
RNS (rhinoscopic)
Time frame: 2 months
OFS (oropharyngoscopic)
Time frame: 2 months
PRNS (post-rhynoscopic)
Time frame: 2 months
Referring physician
Time frame: 2 months
PHD ( pathohistological findings)
Time frame: 2 months
Surgery
Time frame: 2 months
Outcome
Time frame: 2 months
Recurrence
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drazen Shejbal principal investigator
Varazdin General Hospital, Varazdin, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoid Vegetation, run by Varazdin General Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.