Side EffectsNCT04204681
Tonsillar Retractor-induced Subacute Submassive Tongue Edema
An observational study of Side Effects and Tonsil Hypertrophy, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to detect tongue edema induced by the pressure exerted by tonsillar retractor; edema detection was made through tongue area measurement using ultrasonography (USG) in pediatric patients who underwent tonsillectomy surgeries. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Side Effects, Tonsil Hypertrophy, Children, Only
- What is being tested?
- Ultrasonography imaging
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Sep 2019
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 16 years or younger who were to undergo tonsillectomy surgery were eligible for inclusion in this group. Informed consent was obtained from the parents of all the patients with a clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy (except adenoidectomy surgeries) and were to undergo tonsillectomy surgery.
Who may be able to join
- Patients aged 16 years or younger
- Undergo tonsillectomy surgery
- Patients informed consent obtained from the parents
- Patients aged 16 years or younger
- Patients who did not need tonsillectomy surgery and any head and neck procedures
- Patients who underwent endotracheal intubation under general anesthesia except tonsillectomy and head and neck surgery.
Who cannot join
- Patients aged older than 16 years
- Patients with a history of syndromal craniofacial abnormalities
- Patients with systemic disorders and other otolaryngologic problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tonsillar Retractor-induced Subacute Submassive Tongue Edema: A New Cause of Late Respiratory Complications in Pediatric Patients Undergoing Tonsillectomy and a Condition Detected by Ultrasonography
This study aimed to detect tongue edema induced by the pressure exerted by tonsillar retractor; edema detection was made through tongue area measurement using ultrasonography (USG) in pediatric patients who underwent tonsillectomy surgeries.
Read the detailed description
The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue edema through USG examination and to educate clinicians about the association between subacute tongue edema and tonsillar retractor in pediatric patients.
- Conditions
- Side Effects, Tonsil Hypertrophy, Children, Only
- Being tested
- Ultrasonography imaging
- Keywords
- ultrasonography, children, tonsil, diagnostic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography imagingDiagnostic test
This study aimed to measure the tongue areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue areas.
| Study group | Role | What they receive |
|---|---|---|
| Study | Patients aged 16 years or younger who were to undergo tonsillectomy surgery were eligible for inclusion in this group. Tongue areas were measured twice by submental USG.The first measurements (TA2) were done immediately after endotracheal intubation but before insertion and placement of the tonsillar retractor. The second measurements (TA1) were done after tonsillectomy surgery and after removal of the tonsillar retractor but just before extubation. The difference between TA2 and TA1 (i.e., (TA2-TA1) was used to defined the occurrence of tongue edema. Receives: Diagnostic Test: Ultrasonography imaging | |
| Control | This group included patients aged 16 years or younger who did not need tonsillectomy surgery and any head and neck procedures. Tongue areas of the patients were measured twice by submental USG as in the study group. TA1s were done immediately after endotracheal intubation, and TA2s were done at the end of the surgical procedure just before extubation. The difference between TA2 and TA1 (i.e., (TA2-TA1) was used to defined the occurrence of tongue edema. Receives: Diagnostic Test: Ultrasonography imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from preoperative measurement to postoperative measurement in tongue area on the ultrasonography imaging.
This study aimed to evaluate the change from baseline in tongue area on the ultrasonography imaging due to the tonsillar retractor.
Measured: 2018-2019 (6 months)
Secondary outcomes (1)
Detection of edema formation in tongue by using ultrasonography imaging.
This study aimed to measure and detect the tongue edema by using ultrasonography imaging due to the tonsillar retractor.
Measured: 2018-2019 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Nov 2018
- Primary completion1 Apr 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Side EffectsStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkan Onal, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204681
- Sponsor's protocol ID
- 2018/335
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 20 Dec 2019
- 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 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tonsillar Retractor-induced Subacute Submassive Tongue Edema: A New Cause of Late Respiratory Complications in Pediatric Patients Undergoing Tonsillectomy and a Condition Detected by Ultrasonography
- ClinicalTrials.gov ID
- NCT04204681
- Acronym / sponsor ID
- 2018/335
- Conditions
- Side Effects, Tonsil Hypertrophy, Children, Only
- Keywords
- ultrasonography, children, tonsil, diagnostic imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 19 Dec 2019 (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.
This study aimed to detect tongue edema induced by the pressure exerted by tonsillar retractor; edema detection was made through tongue area measurement using ultrasonography (USG) in pediatric patients who underwent tonsillectomy surgeries.
Detailed description
The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue edema through USG examination and to educate clinicians about the association between subacute tongue edema and tonsillar retractor in pediatric patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Diagnostic Test: Ultrasonography imagingPatients aged 16 years or younger who were to undergo tonsillectomy surgery were eligible for inclusion in this group. Tongue areas were measured twice by submental USG.The first measurements (TA2) were done immediately after endotracheal intubation but before insertion and placement of the tonsillar retractor. The second measurements (TA1) were done after tonsillectomy surgery and after removal of the tonsillar retractor but just before extubation. The difference between TA2 and TA1 (i.e., (TA2-TA1) was used to defined the occurrence of tongue edema. |
| Control | – | Diagnostic Test: Ultrasonography imagingThis group included patients aged 16 years or younger who did not need tonsillectomy surgery and any head and neck procedures. Tongue areas of the patients were measured twice by submental USG as in the study group. TA1s were done immediately after endotracheal intubation, and TA2s were done at the end of the surgical procedure just before extubation. The difference between TA2 and TA1 (i.e., (TA2-TA1) was used to defined the occurrence of tongue edema. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 16 years or younger who were to undergo tonsillectomy surgery were eligible for inclusion in this group. Informed consent was obtained from the parents of all the patients with a clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy (except adenoidectomy surgeries) and were to undergo tonsillectomy surgery.
Key inclusion criteria (6 listed)
- Patients aged 16 years or younger
- Undergo tonsillectomy surgery
- Patients informed consent obtained from the parents
- Patients aged 16 years or younger
- Patients who did not need tonsillectomy surgery and any head and neck procedures
Key exclusion criteria (3 listed)
- Patients aged older than 16 years
- Patients with a history of syndromal craniofacial abnormalities
- Patients with systemic disorders and other otolaryngologic problems
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 |
|---|---|---|
| Ultrasonography imagingThis study aimed to measure the tongue areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue areas. | Diagnostic test | Control, Study |
Primary outcome
Change from preoperative measurement to postoperative measurement in tongue area on the ultrasonography imaging.
Time frame: 2018-2019 (6 months)
This study aimed to evaluate the change from baseline in tongue area on the ultrasonography imaging due to the tonsillar retractor.
1 secondary outcome
Detection of edema formation in tongue by using ultrasonography imaging.
Time frame: 2018-2019 (6 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 20 Dec 2019.
- 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 Side Effects and Tonsil Hypertrophy, run by Selcuk 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 6 inclusion and 3 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 20 Dec 2019. 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?
Change from preoperative measurement to postoperative measurement in tongue area on the ultrasonography imaging. (time frame: 2018-2019 (6 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 20 Dec 2019.