Sleep ApneaNCT06184477
The Relationship Between Prolonged Hospitalization and Surgical Experience in Pediatric Tonsillectomy Cases.
An observational study of Sleep Apnea and Tonsillitis Recurrent, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Guided by the expertise of a seasoned surgeon at the tertiary care hospital, the training program includes performing tonsillectomy starting from the 6th month. The clinical protocol at the hospital dictates a standard one-night hospital stay for all patients, but there is potential to extend the duration in specific… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Sleep Apnea, Tonsillitis Recurrent
- What is being tested?
- PEDIATRIC TONSILLECTOMY; SURGICAL EXPERIENCE AND PROLONGED HOSPITALIZATION
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 9 Feb 2024
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A retrospective analysis was conducted on tonsillectomy patients under the age of 18, who underwent surgery at our clinic between 2019 and 2023.
Who may be able to join
- Patients under 18 years of age having tonsillectomy surgery
- Patients whose records are available in the hospital archive
Who cannot join
- Inadequate information in files
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Tonsillectomy: Surgical Experience And Prolonged Hospitalization
Guided by the expertise of a seasoned surgeon at the tertiary care hospital, the training program includes performing tonsillectomy starting from the 6th month. The clinical protocol at the hospital dictates a standard one-night hospital stay for all patients, but there is potential to extend the duration in specific cases. The study endeavors to explore the correlation between extended hospitalization, surgical proficiency, patient-specific factors, and postoperative complications in pediatric patients who underwent tonsillectomy and/or adenotonsillectomy at the clinic.
- Conditions
- Sleep Apnea, Tonsillitis Recurrent
- Being tested
- PEDIATRIC TONSILLECTOMY; SURGICAL EXPERIENCE AND PROLONGED HOSPITALIZATION
- Keywords
- Tonsillectomy, Prolonged hospitalization
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEDIATRIC TONSILLECTOMY; SURGICAL EXPERIENCE AND PROLONGED HOSPITALIZATIONOther
we aim to compare hospitalization times of pediatric patients that operated by expert surgeon or young surgeon
| Study group | Role | What they receive |
|---|---|---|
| prolonged hospitalization after tonsillectomy | Prolonged hospitalization refers to prolonged discharge time and readmission. Receives: Other: PEDIATRIC TONSILLECTOMY; SURGICAL EXPERIENCE AND PROLONGED HOSPITALIZATION | |
| normal hospitalization time | normal hospitalization time for pediatric patients accepted as 1 night stay. Receives: Other: PEDIATRIC TONSILLECTOMY; SURGICAL EXPERIENCE AND PROLONGED HOSPITALIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospitalization lasting more than 24 hours
Measured: december'23- january'24
Secondary outcomes (1)
Incidence of postoperative complications
incidence of bleeding, respiratory problems
Measured: december'23- january'24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Dec 2023
- Primary completion5 Dec 2023
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184477
- Sponsor's protocol ID
- 15
- Status last verified
- May 2024
- First submitted
- 9 Dec 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Tonsillectomy: Surgical Experience And Prolonged Hospitalization
- ClinicalTrials.gov ID
- NCT06184477
- Acronym / sponsor ID
- 15
- Conditions
- Sleep Apnea, Tonsillitis Recurrent
- Keywords
- Tonsillectomy, Prolonged hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 28 Dec 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.
Guided by the expertise of a seasoned surgeon at the tertiary care hospital, the training program includes performing tonsillectomy starting from the 6th month. The clinical protocol at the hospital dictates a standard one-night hospital stay for all patients, but there is potential to extend the duration in specific cases. The study endeavors to explore the correlation between extended hospitalization, surgical proficiency, patient-specific factors, and postoperative complications in pediatric patients who underwent tonsillectomy and/or adenotonsillectomy at the clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prolonged hospitalization after tonsillectomy | – | Other: PEDIATRIC TONSILLECTOMY; SURGICAL EXPERIENCE AND PROLONGED HOSPITALIZATIONProlonged hospitalization refers to prolonged discharge time and readmission. |
| normal hospitalization time | – | Other: PEDIATRIC TONSILLECTOMY; SURGICAL EXPERIENCE AND PROLONGED HOSPITALIZATIONnormal hospitalization time for pediatric patients accepted as 1 night stay. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A retrospective analysis was conducted on tonsillectomy patients under the age of 18, who underwent surgery at our clinic between 2019 and 2023.
Key inclusion criteria (2 listed)
- Patients under 18 years of age having tonsillectomy surgery
- Patients whose records are available in the hospital archive
Key exclusion criteria (1 listed)
- Inadequate information in files
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEDIATRIC TONSILLECTOMY; SURGICAL EXPERIENCE AND PROLONGED HOSPITALIZATIONwe aim to compare hospitalization times of pediatric patients that operated by expert surgeon or young surgeon | Other | normal hospitalization time, prolonged hospitalization after tonsillectomy |
Primary outcome
Incidence of hospitalization lasting more than 24 hours
Time frame: december'23- january'24
1 secondary outcome
Incidence of postoperative complications
Time frame: december'23- january'24
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 3 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sleep Apnea and Tonsillitis Recurrent, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 3 May 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 Turkey (Türkiye). 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?
Incidence of hospitalization lasting more than 24 hours (time frame: december'23- january'24). 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 3 May 2024.