Swallowing Impairment After TonsillectomyNCT06927427
Evaluation of Swallowing Impairment After Tonsillectomy
A study testing fiberoptic endoscopic evaluation of swallowing (FEES) in people with Swallowing Impairment After Tonsillectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
the investigator will evaluate the swallowing pattern of the patients pre-operative and will follow them up at day 15 after tonsillectomy by using Careful history taking and Fiberoptic endoscopic evaluation of swallowing (FEES). Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Swallowing Impairment After Tonsillectomy
- What is being tested?
- fiberoptic endoscopic evaluation of swallowing (FEES)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jan 2025
- Phase
- Interventional
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients undergoing tonsillectomy.
- Age group (from 7-18 years).
- Patients of either gender.
Who cannot join
- Patients younger than 7 years or older than 18 years.
- Patients with neurological diseases and genetic syndromes.
- Patients with history of swallowing disorders prior to tonsillectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Swallowing Impairment After Tonsillectomy: A Cohort Study
the investigator will evaluate the swallowing pattern of the patients pre-operative and will follow them up at day 15 after tonsillectomy by using Careful history taking and Fiberoptic endoscopic evaluation of swallowing (FEES).
Read the detailed description
All patients will be evaluated pre-operative by history taking using the Arabic version of Eating Assessment Tool (EAT-10) questionnaire and will be examined by Fiberoptic endoscopic evaluation of swallowing (FEES). All patients will be operated by the same surgical technique. Patients will be directed to return back on the 15th day post-operative after tonsillectomy and they will be subjected to history taking using the Arabic version of Eating Assessment Tool (EAT-10) questionnaire and they will be examined by Fiberoptic endoscopic evaluation of swallowing (FEES).
- Careful history taking The history of the patients will be taken using the Arabic version of the Eating Assessment Tool (EAT-10) questionnaire. The patient will rate the problem on a scale of 0 to 4 (0 means no problem; 4 means severe problem). A score of 3 or more on the EAT-10 is considered dysphagia.
- Fiberoptic endoscopic evaluation of swallowing (FEES). Using flexible endoscopy (the flexible nasopharyngeal video-fiberscope Henke-Sass-Wolf, 4.3mm in diameter connected to Lemke video camera). The patient will be given a colored thin fluid to keep in their mouth and then swallow following the instructions of the examiner, then the examination will be repeated using semisolids (1 teaspoon of yogurt) and using solids (piece of bread). The evaluation of swallowing will involve four items: early spill of food (delayed triggering), aspiration, penetration, and retention (residue). And the results will be recorded.
- Being tested
- fiberoptic endoscopic evaluation of swallowing (FEES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic endoscopic evaluation of swallowing (FEES)Procedure or surgery
Using flexible endoscopy, the patient will be given a colored thin fluid to keep in their mouth and then swallow following the instructions of the examiner, then the examination will be repeated using semisolids (1 teaspoon of yogurt) and using solids (piece of bread). The evaluation of swallowing will involve four items: early spill of food (delayed triggering), aspiration, penetration, and retention (residue). And the results will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Post tonsillectomy group | Other | Not described Receives: Procedure: fiberoptic endoscopic evaluation of swallowing (FEES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of swallowing impairment after tonsillectomy
To evaluate the swallowing process in children after tonsillectomy and detect the occurance of dysphagia. using the Arabic version of the Eating Assessment Tool (EAT-10) questionnaire, the patient will rate the problem on a scale of 0 to 4 (0 means no problem; 4 means severe problem). A score of 3 or more on the EAT-10 is considered dysphagia. And Fiberoptic endoscopic evaluation of swallowing (FEES), the evaluation of swallowing will involve four items: early spill of food (delayed triggering), aspiration, penetration, and residue.
Measured: 15 days after tonsillectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing Impairment After TonsillectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa A Mansour, MBBCH, Principal investigator, OtoRhinoLaryngology, head and neck surgery resident, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927427
- Sponsor's protocol ID
- FMASU MS75/2024
- Status last verified
- Feb 2024
- First submitted
- 4 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Swallowing Impairment After Tonsillectomy: A Cohort Study
- ClinicalTrials.gov ID
- NCT06927427
- Acronym / sponsor ID
- FMASU MS75/2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 15 Apr 2025 (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.
the investigator will evaluate the swallowing pattern of the patients pre-operative and will follow them up at day 15 after tonsillectomy by using Careful history taking and Fiberoptic endoscopic evaluation of swallowing (FEES).
Detailed description
All patients will be evaluated pre-operative by history taking using the Arabic version of Eating Assessment Tool (EAT-10) questionnaire and will be examined by Fiberoptic endoscopic evaluation of swallowing (FEES). All patients will be operated by the same surgical technique. Patients will be directed to return back on the 15th day post-operative after tonsillectomy and they will be subjected to history taking using the Arabic version of Eating Assessment Tool (EAT-10) questionnaire and they will be examined by Fiberoptic endoscopic evaluation of swallowing (FEES).
- Careful history taking The history of the patients will be taken using the Arabic version of the Eating Assessment Tool (EAT-10) questionnaire. The patient will rate the problem on a scale of 0 to 4 (0 means no problem; 4 means severe problem). A score of 3 or more on the EAT-10 is considered dysphagia.
- Fiberoptic endoscopic evaluation of swallowing (FEES). Using flexible endoscopy (the flexible nasopharyngeal video-fiberscope Henke-Sass-Wolf, 4.3mm in diameter connected to Lemke video camera). The patient will be given a colored thin fluid to keep in their mouth and then swallow following the instructions of the examiner, then the examination will be repeated using semisolids (1 teaspoon of yogurt) and using solids (piece of bread). The evaluation of swallowing will involve four items: early spill of food (delayed triggering), aspiration, penetration, and retention (residue). And the results will be recorded.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post tonsillectomy group | Other | Procedure: fiberoptic endoscopic evaluation of swallowing (FEES) |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients undergoing tonsillectomy.
- Age group (from 7-18 years).
- Patients of either gender.
Key exclusion criteria (3 listed)
- Patients younger than 7 years or older than 18 years.
- Patients with neurological diseases and genetic syndromes.
- Patients with history of swallowing disorders prior to tonsillectomy.
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 |
|---|---|---|
| fiberoptic endoscopic evaluation of swallowing (FEES)Using flexible endoscopy, the patient will be given a colored thin fluid to keep in their mouth and then swallow following the instructions of the examiner, then the examination will be repeated using semisolids (1 teaspoon of yogurt) and using solids (piece of bread). The evaluation of swallowing will involve four items: early spill of food (delayed triggering), aspiration, penetration, and retention (residue). And the results will be recorded. | Procedure or surgery | Post tonsillectomy group |
Primary outcome
evaluation of swallowing impairment after tonsillectomy
Time frame: 15 days after tonsillectomy
To evaluate the swallowing process in children after tonsillectomy and detect the occurance of dysphagia. using the Arabic version of the Eating Assessment Tool (EAT-10) questionnaire, the patient will rate the problem on a scale of 0 to 4 (0 means no problem; 4 means severe problem). A score of 3 or more on the EAT-10 is considered dysphagia. And Fiberoptic endoscopic evaluation of swallowing (FEES), the evaluation of swallowing will involve four items: early spill of food (delayed triggering), aspiration, penetration, and residue.
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 15 Apr 2025.
- Individual participant dataSharing planned: Yes. all data will be shared once study is completed
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.
Alaa A Mansour, MBBCH principal investigator
OtoRhinoLaryngology, head and neck surgery resident, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fiberoptic endoscopic evaluation of swallowing (FEES) in people with Swallowing Impairment After Tonsillectomy, run by Ain Shams University at 1 site in Egypt.
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 3 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 15 Apr 2025. 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 Egypt. 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?
evaluation of swallowing impairment after tonsillectomy (time frame: 15 days after tonsillectomy). 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 15 Apr 2025.