Evaluation of Swallowing Impairment After Tonsillectomy

NCT06927427 | Completed DMC

• 1 other identifier: FMASU MS75/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Swallowing Impairment After Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  15 days after tonsillectomy

Study Arms (1)

Post tonsillectomy group

OTHER

Procedure: fiberoptic endoscopic evaluation of swallowing (FEES)

Interventions

fiberoptic endoscopic evaluation of swallowing (FEES) PROCEDURE

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.

Post tonsillectomy group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 1181, Egypt

Location

Study Officials

• Alaa A Mansour, MBBCH

  OtoRhinoLaryngology, head and neck surgery resident, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 15, 2025
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: once study is completed
• Access Criteria: free

Locations

EG (1)