Evaluation of Swallowing Impairment After Tonsillectomy

April 14, 2025 updated by: Ain Shams University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

  1. 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.
  2. 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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 1181
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients undergoing tonsillectomy.
  2. Age group (from 7-18 years).
  3. Patients of either gender.

Exclusion Criteria:

  1. Patients younger than 7 years or older than 18 years.
  2. Patients with neurological diseases and genetic syndromes.
  3. Patients with history of swallowing disorders prior to tonsillectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Post tonsillectomy group
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 days after tonsillectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Alaa A Mansour, MBBCH, OtoRhinoLaryngology, head and neck surgery resident, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS75/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all data will be shared once study is completed

IPD Sharing Time Frame

once study is completed

IPD Sharing Access Criteria

free

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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