Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

All Conditions

Neoplasms

Laryngeal Diseases

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

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

Describe anatomical and morphological characteristics o phonatory movement of PEM in laryngectomy patients

High - speed video endoscopy (HSV)

acoustic program (lingWAVES - Voice and speech analyser) - measuring the values of acoustic parameters in voice recordings

Acoustic voice analysis

Quality of life questionnaire

Željka Laksar Klarić, M.D.

Ana Đanić Hadžibegović, Assoc. Prof

Andrijana Včeva, Full Prof

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

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.

Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

Dependencies of Acoustic Signal and Image Recordings of Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients Using High-speed Video Endoscopy and a Biomechanical Model

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.

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)

Measurement of the longest possible relaxed phonation of the voice "a" by a speech therapist

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)

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.

Clinical Hospital Centre Zagreb

Josip Juraj Strossmayer University of Osijek

Osijek University Hospital

Symptoms and General Pathology

Pain, Postoperative

Pain

Cough

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Adjuvants, Anesthesia

Psychotropic Drugs

Anesthetics

Dexmedetomidine

Midazolam

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

patients receive dexmedetomidine infusion

dexmedetomidine infusion at 0.5 µg•kg-1 for 10 min before tracheotomy then adjusted to 0.3µg•kg-1•h-1

Dexmedetomidine Injectable Product

midazolam infusion at 0.05 mg•kg-1 ten minutes before tracheotomy then adjusted to 0.02mg•kg-1•h-1

Midazolam injection

Wenxian Li, PhD

Background: During emergence from anesthesia for partial and total laryngectomy, severe airway reflex and systemic hypertension during recovery may lead to pneumoderm, hemorrhage, pneumomediastinum or pneumothorax. Dexmedetomidine is a selective α2-adrenoreceptor agonist that has sedative, analgesic, and sympatholytic properties. It has been reported dexmedetomidine can attenuate coughing reflex and prevent emergence agitation without delaying recovery and respiratory depression from general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine compared with midazolam on cough suppression and recovery quality during emergence from general anesthesia after partial and total laryngectomy.

Methods American Society of Anesthesiologists physical status I-II male adults undergoing elective laryngectomy under sevoflurane anesthesia were recruiting and randomly allocated to receive either dexmedetomidine(Group D, n = 60) infusion at 0.5 µg•kg-1 for 10 min before tracheotomy, then adjusted to 0.3µg•kg-1•h-1 or midazolam (Group M, n = 60) infusion at 0.05 mg•kg-1 ten minutes before tracheotomy, then adjusted to 0.02mg•kg-1•h-1. The primary outcome measure was the incidence and severity of cough. Hemodynamics, pain intensity \[Visual Analogue Scale (VAS)\] and Ramsay sedation scale (RSS) were also evaluated at awake, patients returning to ward from post anesthesia care unit (PACU),2h after surgery. postoperative sufentanil consumption, recovery time and the incidence of concerning adverse effects were recorded.

Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer

A Randomized Controlled Trial of the Effect of Dexmedetomidine Compared With Midazolam on Airway Reflex and Recovery Quality During Emergence From General Anesthesia After Partial and Total Laryngectomy

Coughing severity was classified using the 3-point scale.:1=mild (single) cough, 2=moderate (≤5 s) cough, and 3=severe (\>5 s) cough.

Assessed by Visual Analogue Scale (VAS), (0, no pain; 10, the worst pain intolerable)

Assessed by Ramsay sedation scale (RSS),1, Anxious or restless or both,2, Cooperative, orientated and tranquil,3,Responding to commands,4,Brisk response to stimulus,5,Sluggish response to stimulus,6, No response to stimulus.

desaturation,shivering,drowsiness, delirium,hypertension,hypotension,itching,arrhythmia,respiratory depression

Eye & ENT Hospital of Fudan University

Rare Diseases

Laryngeal Cancer

Each patient will participate in a cycle of four sessions, over four months. Each will be carried out with five patients, in order to facilitate exchanges. The aim is to organize eight groups that will each complete a cycle. This will allow to include about forty patients in the study.

Patients who don't want to participate in the exchange groups but agree to be included in the control group. They will have to complete the quality of life questionnaires four months apart.

Estimation of 10 patients included.

Angèle Germon

Diane Evrard, MD

This research is conducted with the aim of improving the quality of life of laryngectomized patients and their entourage. Worldwide, there are 185,000 new cases of laryngeal cancer per year. In Europe, between 2000 and 2007, the crude annual incidence rates of these cancers were 4.6/100,000 with a 5-year survival rate of 61%.

In France, about 30 to 35% of cancers of the upper aerodigestive tract are localized to the larynx, or about 43,000 cases per year. Most patients are men (89%) between 50 and 70 years old. One of the treatments for these cancers is to perform an excision of the larynx thus removing the entire tumor, it is the total laryngectomy. The trachea is thus permanently removed from the skin and the digestive tract becomes independent.

In the ENT department of Bichat Hospital, there is an average of fourteen surgeries of this type per year, over the last three years. The direct consequences of total laryngectomy are multiple:

* loss of phonation (voice) and need to learn to speak again through speech therapy;
* Disappearance of oral-nasal breathing (and therefore loss of smell, or even taste);
* Disappearance of the capacity of the effort with closed glottis (used in the acts of daily life: defecation, sexual act in men, etc.);
* Impairment of body image and sometimes self-esteem.

For these reasons, it is essential to accompany patients post-operative to help them understand their body image and mitigate the direct and indirect consequences of this intervention. There are very few organizations to assist these patients in this life change.

To support laryngectomized patients, the study will test and validate the creation of self-help and support groups. The study will include laryngectomized patients who wish and can participate in these groups.

The sessions will take place as follows:

* 1st: presentation of each, answers to questions;
* 2nd: intervention of the association of the mutilated of the voice;
* 3rd: questions / answers with a resource patient (laryngectomized for 13 years in Bichat);
* 4th: grouping of all participants to assess patient satisfaction.

To assess the benefit of these meetings, a global quality of life questionnaire (WHOQOL-BREF) and an ENT-specific questionnaire (EORTC QLQH\&n43) will be given to patients before the first session and retrieved beforehand. The patient will be able to participate in the sessions only if the questionnaires are submitted. The questionnaires are accompanied by a free text part, so that the person fills in the keys that the workshops have brought him. Patients who cannot participate in the exchange groups for geographical or personal reasons will constitute a control group. They will also complete the two questionnaires four months apart. The number of patients registered and the participation rate at each session will be evaluated.

Workshops and Exchange Groups for Laryngectomized Patients

The aim is to show a difference in patients' overall quality of life scores via the WHOQOL-BREF questionnaire, before and after the program.

The aim is to show a difference in quality of life scores specific to ENT EORTC QLQH\&n43, before and after the program.

Assistance Publique - Hôpitaux de Paris

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Hypopharyngeal Cancer

Antineoplastic Agents

Dermatologic Agents

Pembrolizumab

Docetaxel

Immune Checkpoint Inhibitors

Cisplatin

Benzoyl Peroxide

Antineoplastic Agents, Immunological

Standard-Arm:

Short Induction (IC-1):

T = Docetaxel 75 mg/m\^2 i.v. day 1 P = Cisplatin 75 mg/m\^2 i.v. day 1 Response evaluation will be performed in week 4 after IC-1 by endoscopic estimation of tumor-surface shrinkage (ETSS) to select nonresponders for early total laryngectomy (TL). Responders receive further 2 cycles TP followed by radiotherapy (RT) starting week 11.

ETSS \< 30% (Nonresponder):

- TL + adjuvant RT or chemo-radiotherapy (CRT) according the decision of the tumor board

ETSS \>=30% (Responder):

2 further TP cycles (IC-2 in week 5-7 and IC-3 in week 8-10; same doses as IC-1) Radiotherapy (RT) is accelerated IMRT with concomitant boost with total dose of 69.6 Gy applied over 5.5 weeks to all tumor localizations; clinically non-affected neck levels receive 51.6 Gy.

\* protocol is according exactly to the DeLOS-II protocol arm A in Dietz et al. Ann Oncol. 2018 Oct 1;29(10):2105-2114

Intervention arm aka Experimental-Arm:

Treatment same as for patients randomized into the standard arm A + application of KEYTRUDA® (pembrolizumab), i.v., in 3-week cycle (q3w) 200 mg, starting day 1; for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.

200 mg KEYTRUDA® i. v. in 3-week cycle (q3w)

KEYTRUDA®

Andreas Dietz, MD PhD

Susanne Wiegand, MD PhD

ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \< 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.

ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \< 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.

The primary objective of ELOS is to compare laryngectomy-free survival (LFS) achieved by adding KEYTRUDA® (pembrolizumab) to standard treatment and LFS after standard treatment according to the DeLOS-II protocol in advanced LHNSCC curable by laryngectomy.

Hypothesis: Adding PD-1 inhibition by pembrolizumab to organ-preservation chemoradiation treatment improves laryngectomy-free survival (LFS) compared to standard treatment according to the DeLOS-II protocol.

The secondary objectives are to compare Quality of Swallowing (QoS) assessed by FEES, event free survival (EFS) and overall survival (OS) achieved by adding KEYTRUDA® (pembrolizumab) to standard treatment and QoS, EFS and OS after standard treatment according to the DeLOS-II protocol in advanced LHNSCC. In general, the main interest in trials focusing on improving quality and degree of larynx organ preservation is late functional (in particular "swallowing") outcome. Current instruments assessing hrQoL are less meaningful than direct objective assessment of swallowing utilizing physical examination like FEES. FEES is a well approved and reliable method and allows clear scoring of quality of swallowing for instance by applying the Rosenbek Scale. Therefore, the investigators decided to avoid any questionnaires for this assessment including those approved for use in head and neck cancer, as they fail to specifically address the main study outcome, functional larynx organ preservation.

Hypothesis: Adding PD-1 inhibition by KEYTRUDA® (pembrolizumab) to organ-preservation chemoradiation treatment improves QoS, EFS and OS compared to standard treatment according to the DeLOS-II protocol. EFS events are defined as any event either in interfering with proper larynx organ function (independent of the cause, tumor- or treatment related), relapse (local, loco-regional, or distant), or death.

Prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicenter larynx organ-preservation trial with randomization in a 1:1 ratio into standard arm vs. investigational arm with a flexible follow-up of 24-48 months

European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]

ELOS - Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiation Compared to Additional PD-1 Inhibition in CPS ≥1 Advanced Laryngeal/Hypopharyngeal Cancer Suitable for Laryngectomy Selected After Early Response Evaluation

Laryngectomy-free survival (LFS) is the survival of the patient with larynx at place aka survival without laryngectomy, in the intent-to-treat population (follow-up of the total cohort until 24 months after randomization of the last patient accrued). Laryngectomy or death from any cause count as event.

We measure LFS in the intent-to-treat population as the survival time of patients with larynx at place, which is the time interval from date of randomization until date of LFS event (follow-up of the total cohort until 24 months after randomization of the last patient accrued). Laryngectomy or death from any cause count as LFS event. Patients lost to follow-up will be censored at date of last visit with larynx at place. Recruitment will be over 2 years and all patients will be followed up for at least 2 years, resulting in a maximum follow-up time of 4 years.

Overall survival (OS) is the survival of the patient without death from any cause, in the intent-to-treat population (follow-up of the total cohort until 24 months after randomization of the last patient accrued).

We measure OS in the intent-to-treat population as the survival time of patients as the time interval from date of randomization until date of death from any cause (follow-up of the total cohort until 24 months after randomization of the last patient accrued). Patients lost to follow-up will be censored at date of last visit. Recruitment will be over 2 years and all patients will be followed up for at least 2 years, resulting in a maximum follow-up time of 4 years.

QoS will be assessed by fiber-endoscopic estimation of swallowing (FEES) at time of randomization and 6 and 24 months after first cycle induction chemo using the Rosenbek Scale (RS). De novo dysphagia (RS for aspiration and airway invasion/penetration \>1) or exacerbation of existing dysphagia RS 2-5 to RS ≥6 (aspiration), is loss of freedom from laryngo-esophageal dysfunction (FFLED; event). An event might also be persistence of either tracheostoma or gastric tube at 24 months (event at 24 months) or total laryngectomy or death from any cause.

We measure FFLED in the intent-to-treat population as time interval from date of randomization until date of event (follow-up of the total cohort until 24 months after randomization of the last patient accrued). Patients lost to follow-up will be censored at date of last visit without event. Recruitment will be over 2 years and all patients will be followed up for at least 2 years, resulting in maximum follow-up of 4 years.

Event-free survival (EFS) is the survival of the patient without any event. Total laryngectomy (TL), progressing disease, occurrence of new lesions, local or nodal relapse, distant metastases or death from any cause count as event.

We measure EFS in the intent-to-treat population as the time interval from date of randomization until date of any event (follow-up of the total cohort until 24 months after randomization of the last patient accrued). Patients lost to follow-up will be censored at date of last visit without event. Recruitment will be over 2 years and all patients will be followed up for at least 2 years, resulting in a maximum follow-up time of 4 years.

Event-free survival (EFS) is the survival of the patient without any event. As early total laryngectomy (TL) of nonresponders with ETSS \<30% assessed by early response evaluation in week 4 is per-protocol therapy of LHSCC patients, which according to insufficient response to IC-1 cannot be selected for further 2 cycles TP followed by RT to achieve larynx organ-preservation, the alternative analysis of EFS will not consider early TL of nonresponders as event. However, progressing disease, occurrence of new lesions, local or nodal relapse, distant metastases or death from any cause and TL \>2 months after IC-1 or loss of FFLED count as event.

We measure EFS in the intent-to-treat population as the time interval from date of randomization until date of event. Patients lost to follow-up will be censored at date of last visit without event. Recruitment will be over 2 years and all patients will be followed up for at least 2 years, resulting in a maximum follow-up time of 4 years.

University of Göttingen

University of Jena

University of Cologne

University of Ulm

University of Regensburg

Wuerzburg University Hospital

Technical University of Munich

Ernst von Bergmann Hospital

Universitätsmedizin Mannheim

University of Kiel

University of Leipzig

Univ.-Prof. Dr. med. Andreas Dietz, Chairman, Clinic of Otolaryngology, Head and Neck Surgery & Dept. Head Medicine and Oral Health

Behaviors and Mental Disorders

Quality of Life

Oculocerebral Syndrome With Hypopigmentation

Patients who have undergone total laryngectomy and completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy

Filling out questionnaires, measuring maximum phonation and diadochokinesis

Andrijana Včeva, Prof., Ph.D.

Željka Laksar Klarić

Self-Evaluation of Communication Experiences after Laryngectomy (SECEL) questionnaire has been developed, with the aim of evaluating rehabilitation needs and the psychosocial care for patients with laryngeal cancer. This short but comprehensive self-report instrument measures the perceived adjustment to communication experiences and is intended to aid in determining counselling needs in patients with laryngeal cancer who are treated with a laryngectomy. The first aim of this study is to evaluate the translation, psychometric properties and cultural adaptation of a Croatian version of the SECEL questionnaire. Secondary aim is to examine relationship between the Croatian version of the SECEL and the Short Form Health Survey (SF-36) and the Voice Handicap Index (VHI) questionnaires and to examine relationship between objective voice measures and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR).

At the first visit all patients included in the study were asked to complete the Croatian version of the Voice Handicap Index (VHI), Short Form Health Survey (SF-36) and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR) questionnaire.

SECEL 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). 35 items are grouped according to 3 subscales named General (0-15 score range), Environment (0-42 score range) and Attitude (0-45 score range), and item number 35 is a separate question: "Do you talk the same amount now as before your laryngectomy?" and is rated with a "yes," "more," and "less" rating category. The overall numerical score varies from 0 to 102, and the higher score indicates greater difficulties and worse postoperative speech-communication adjustment.

The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and also scored with Likert scale with overall score from 0 to 120. Higher scores indicate a greater handicap.

The Short Form Health Survey (SF-36) is a multi-purpose short-form health survey that consist of 36 questions divided in eight scales and clustered into two groups: physical and mental health. Each item was standardized (range 0-100), with a higher score representing better QoL.

The objective assessment includes the maximum phonation time measured in seconds as common clinical measure of glottal efficiency, diadochokinesis of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s) or how quickly subjects can produce a series of rapid sounds which is a measure of speech efficiency.

All patients will fulfil the SECEL:HR questionnaire twice, two weeks after the initial test and that will be considered as a re-test of the SECEL reliability analysis.

Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire

Validation and Cross-cultural Adaptation of Croatian Self-Evaluation of Communication Experiences After Laryngectomy Questionnaire

Completing the Croatian version of the Short Form Health Survey (SF-36) questionnaire. The Short Form Health Survey consist of 36 questions divided in eight scales and clustered into two groups: physical and mental health. Each item is standardized (range 0-100), with a higher score representing better QoL.

Completing the Croatian version of the Voice Handicap Index (VHI) questionnaire. The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and scored with Likert scale (0-never, 1-almost never, 2-sometimes, 3-almost always, 4-always) with overall score from 0 to 120.

The maximum phonation time (measured in seconds) for which a person can sustain a vowel sound when produced on 1 deep breath at a comfortable pitch and loudness and is a common clinical measure of glottal efficiency.

The diadochokinesis measures how quickly an individual can accurately produce a series of rapid sounds of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s) and is a measure of speech efficiency.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients	NCT05561920	Larynx Cancer Laryngectomy; S...	High - speed vi... Acoustic voice ... Quality of life...	18 Years - 90 Years	Osijek University Hospital
Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer	NCT03918889	Laryngectomy; S...	Dexmedetomidine... Midazolam injec...	35 Years - 65 Years	Eye & ENT Hospital of Fudan University
Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer	NCT03918889	Laryngectomy; S...	Dexmedetomidine... Midazolam injec...	35 Years - 65 Years	Eye & ENT Hospital of Fudan University
Workshops and Exchange Groups for Laryngectomized Patients	NCT06077643	Laryngectomy; S... Laryngeal Cance...		18 Years -	Assistance Publique - Hôpitaux de Paris
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]	NCT06137378	Squamous Cell C... Hypopharyngeal ... Laryngeal Squam... Laryngeal Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Laryngeal Squam... Laryngectomy; S... Laryngeal Cance... Laryngeal Neopl...	KEYTRUDA®	18 Years - 70 Years	University of Leipzig
Workshops and Exchange Groups for Laryngectomized Patients	NCT06077643	Laryngectomy; S... Laryngeal Cance...		18 Years -	Assistance Publique - Hôpitaux de Paris
Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire	NCT05346237	Larynx Neoplasm Laryngectomy; S... Communication Quality of Life	Quality of life...	18 Years - 90 Years	Osijek University Hospital

Spots Global Cancer Trial Database for laryngectomy; status