Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

Recruiting

• Conditions: Larynx Cancer; Laryngectomy; Status
• Interventions: Device: High - speed video endoscopy (HSV); Device: Acoustic voice analysis; Behavioral: Quality of life questionnaire

• Registration Number: NCT05561920
• Lead Sponsor: Osijek University Hospital

Brief Summary

Therapy of advanced cancer of the larynx includes excision of the entire larynx. After the removal of the larynx, the pharyngoesophageal segment (PES) is created by reconstruction of the soft tissue of the pharynx and oesophagus, and its vibration creates a replacement voice. High-speed video endoscopy (HSV) is the only method that visualizes and measures vibration of pharyngoesophageal mucosa (PEM) after laryngectomy. Acoustic characteristics of three forms of the rehabilitated voice of laryngectomized persons (oesophageal voice, tracheoesophageal voice using a speech 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 investigated. In recent years, the development of biomechanical models is created to analyse the vibration of the PES, but still no uniform results have been achieved that would explain whether the parameters obtained 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 laryngectomized patients

Detailed Description

The first aim of this study is to describe phonatory movement of PEM in laryngectomy patients with HSV and then with biomechanical model, analyse these recordings and examine relationship between the obtained parameters and the parameters obtained using the acoustic analysis of the voice of a laryngectomized person. Secondary aim is to assess the impact of loss of voice in terms of psychological and socioeconomic problems in laryngectomy patients using Croatian version of the Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR) questionnaire and to examine whether there is a connection between the parameters obtained from the analysis of acoustic recordings and HSV recordings with the results of the questionnaire i.e., with better or worse postoperative adaptation and satisfaction with the replacement voice.

This is a non-interventional, prospective study of laryngectomised participants who completed oncological treatment and underwent voice rehabilitation. The data will be collected at the Clinical Department for Otorhinolaryngology and Head and Neck Surgery - University Hospital Centre, Osijek, Clinical Department for Otorhinolaryngology and Head and Neck Surgery - University Hospital Centre, Zagreb.

In the first phase of the research, translation and cultural adaptation of a Croatian version of the SECEL questionnaire will be carried out ( ClinicalTrials.gov Identifier: NCT05346237).

Second phase will enrol approximately 50 laryngectomised participants independent from the first phase of research. Data on surgical and oncological treatment, voice rehabilitation method, comorbidities and drug therapy will be collected retrospectively from the patient's medical histories. Ear,nose and throat examination and endoscopic evaluation of swallowing will be performed in order to rule out the presence of non-eligibility criteria. All subjects will fill out a validated questionnaire in Croatian (SECEL:HR). Voice production time will be measured, and subjects will undergo acoustical voice assessment and HSV during voice production. The visualisation of the pharyngoesophageal segment itself will be analysed - phase closure, pharyngoesophageal segment shape (circular, triangular, split side to side, split anterior-posterior, irregular), then the presence and location of visible vibration, and the presence of a mucosal wave. For the processing of HSV videos a computer program will be developed. Based on the collected data, the parameters of the assumed multi-mass coupled biomechanical model will be identified and compared with the acoustic recording of each respondent.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-05
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult laryngectomised patients	Acoustic voice analysis	Patients who have undergone total laryngectomy and completed minimal their 6-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
Adult laryngectomised patients	Quality of life questionnaire	Patients who have undergone total laryngectomy and completed minimal their 6-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
Adult laryngectomised patients	High - speed video endoscopy (HSV)	Patients who have undergone total laryngectomy and completed minimal their 6-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy

Primary Outcome Measures

Name	Time	Method
Acoustic analysis	15 minutes	acoustic program- measuring the quality of voice each laryngectomised patients during phonation of vowel "a". Voice recordings will be analysed in the acoustic program (lingWAVES - Voice and speech analyser)
High speed video endoscopy recordings	15 minutes for each participants	Visual recording of the mucosa of the pharyngoesophageal segment will be performed with High speed video endoscopy (Wolf 5562 ENDOCAM) during the phonation of the letter "a". Recording is performed through the mouth with a rigid endoscope connected to an High speed camera.
Maximum phonation time	2 minutes	Measurement of the longest possible relaxed phonation of the voice "a" by a speech therapist
Croatian version of the SECEL (SECEL:HR) questionnaire.	15 minutes	Completing the Croatian version of the SECEL questionnaire. Questionnaire consists of two parts. The first part examines the relevant general data on the person filling out the questionnaire, while the second part consists of 35 items questionably or statement-designed to examine communication experiences. Patients estimates the incidence of these communication difficulties on the Likert scale (0-never, 1-sometimes, 2-often, 3-always)
Development of Biomechanical model for vibration analysis obtained by High - speed video endoscopy	3 months	The development of the biomechanical model of the PES in order to quantify non-stationary PE-vibrations and drawing conclusions on the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PE-segment. Biomechanical model will identify mathematical dependencies and analyse extracted time signals of the PES opening and contours which will compare video spectral analysis from high- speed video endoscopy imaging and the parameters obtained using the acoustic analysis of the voice of a laryngectomized person.

Trial Locations

Locations (1)

University Hospital Osijek; 🇭🇷 Osijek, Croatia