N/A
N=55
Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients
Larynx Cancer · Laryngectomy; Status
Bottom Line
View on ClinicalTrials.gov: NCT05561920 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: High Speed Video Endoscopy Recordings — 53; 2; 2; 38 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- High-speed video endoscopy (HSV) (Device); Acoustic voice analysis (Device); Quality of life questionnaire (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Osijek University Hospital
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Speed Video Endoscopy Recordings |
53; 2; 2; 38; 16; 1 | — |
| PRIMARY The Measures of Central Tendency and Dispersion in Acoustic Signal - Fundamental Frequency |
100.7 | — |
| PRIMARY The Measures of Central Tendency and Dispersion in Acoustic Signal - Intensity of Substitute Voice |
73 | — |
| PRIMARY The Measures of Central Tendency and Dispersion in Acoustic Signal - Relative Jitter and Shimmer |
13.2; 43.9 | — |
| PRIMARY The Measures of Central Tendency and Dispersion of Maximum Phonation Time (MPT) |
7.7 | — |
| PRIMARY Croatian Version of the SECEL (SECEL:HR) Questionnaire. |
18; 4; 11; 5 | — |
| PRIMARY The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion - Open and Closed Phase Duration (%), Relative Shimmer and Relative Jitter |
0.77; 0.36; 0.99; 2.94 | — |
| PRIMARY The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion - Mean Shimmer |
0.63 | — |
| PRIMARY The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion of Mean Jitter |
0.1 | — |
| PRIMARY The Results of Pharyngoesophageal Segment (PES) Vibration Analysed With the Biomechanical Model Obtained by High - Speed Video Endoscopy - Central Tendency and Dispersion - Fundamental Frequency |
81.37 | — |
Summary
The treatment of advanced laryngeal cancer involves the removal of the entire larynx. After removal of the larynx, the pharyngoesophageal segment (PES) is created by reconstructing the soft tissue of the pharynx and oesophagus, and its vibration creates a substitute voice. High-speed video endoscopy (HSV) is the only method that visualises and measures the vibration of the PES after a laryngectomy. The acoustic characteristics of three forms of rehabilitated voice of laryngectomised individuals (oesophageal voice, tracheoesophageal (TE) voice using a voice prosthesis and electrolarynx) have been satisfactorily described, but the interdependence of acoustic and visual representations of the phonatory movement of the PES is still insufficiently studied. In recent years, biomechanical models have been developed to analyse the vibration of the PES, but consistent results have not yet been obtained that would explain whether the parameters from the analysis of the waveform of the PES can be compared with the parameters obtained from the acoustic analysis of the voice of a laryngectomised patient.Effective rehabilitation focuses on optimising speech and swallowing, which leads to a good integration of the laryngectomised person into society. One step towards achieving this goal is a thorough assessment of their voice and communication experiences, as well as analysing the phonatory movements of the PES using HSV technology.
Eligibility Criteria
Inclusion Criteria
- laryngectomised patients who completed minimal their 6-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
- patients with preserved reading skills
- regular presence at follow-up visits
Exclusion Criteria
- age less than 18 years
- acute respiratory infection of the upper or lower respiratory tract
- other primary cancer in the upper aerodigestive tract or lung
- presence of neurologic or pulmonary diseases
Data sourced from ClinicalTrials.gov (NCT05561920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.