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Идёт набор NCT06439290

Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty

Без фазы С лечением Surgery Larynx Transgenderism Gender Dysphoria

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Phonosurgery, Mastectomy/breast augmentation.
Кому может быть актуально
Состояния в реестре: Surgery, Larynx, Transgenderism, Gender Dysphoria. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes.

Подробное описание

Gender-affirming voice surgery (such as glottoplasty, cricothyroid approximation, thyroplasty and chondrolaryngoplasty), in addition to gender-affirming voice training and hormone therapy, plays an important role in achieving a gender-congruent voice in transgender and gender diverse people. In addition, these interventions are sometimes performed on cisgender men or women who wish to change their voice. However, the impact of these interventions on broad voice characteristics needs to be further investigated.

A thyroid chondroplasty is a procedure in which the cartilage of the larynx is flattened to make the larynx ("Adam's apple") less visible. This procedure is sometimes performed in combination with voice surgery. Although clinically in some cases we observe a temporary lowering of the pitch of the voice during thyroid chondroplasty, little is known in the literature about the impact of this surgery on voice characteristics.

The first purpose is to measure the effect of glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty on a) acoustic voice characteristics (such as the pitch and resonance of the voice), b) perception of femininity/masculinity, c) psychosocial well-being and satisfaction and d) the function of the vocal folds.

Persons undergoing a glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty in the head and neck surgery department are routinely invited to several pre- and postoperative check-up appointments in the head and neck surgery and ear, nose and throat department. These people will be invited to participate in the study in which the data, which are routinely collected preoperatively, 1 week, 1 month, 6 months and 12 months postoperatively during a speech-language pathology (SLP) consultation and a head and neck surgery consultation. These data will be used for scientific research to study the outcome of such surgery on phonation. These pre- and post-operative consultations are clinically standard. During these consultations, a voice assessment and videolaryngostroboscopic examination of the vocal folds are routinely performed.

Recordings and images obtained through these studies can be further processed in the context of this scientific research (such as conducting a listening experiment, analyzing (e.g. using the VALI form) and measuring the video laryngostroboscopy results, etc.).

Secondly, factors (determinants) that influence the effect of previous surgical interventions will be studied within this research.

The third purpose of this study is to develop and validate a laryngeal magnetic resonance imaging (MRI) protocol using a laryngeal surface coil to measure pre- and postoperative anatomical factors (vocal fold length and thickness, thyroarytenoid muscle mass and area) and compare them with the acoustic changes.

Вмешательства

  • Процедура Phonosurgery
    Gender-affirming voice surgery (such as glottoplasty, cricothyroid approximation, thyroplasty and chondrolaryngoplasty), in addition to gender-affirming voice training and hormone therapy, plays an important role in achieving a gender-congruent voice in transgender and gender diverse people. In addition, these interventions are sometimes performed on cisgender men or women who wish to change their voice. However, the impact of these interventions on broad voice characteristics needs to be furthe
  • Процедура Mastectomy/breast augmentation
    Control group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery.

Первичные конечные точки

  • Speaking fo [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
  • FF 1-5 [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
  • Perceptual femininity/masculinity score [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
Вторичные конечные точки (7)
  • Vocal capacity [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
  • Vocal range [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
  • Vocal quality [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
  • Laryngeal function [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
  • PROMs: Voice Handicap Index [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
  • PROMs: Trans Woman Voice Questionnaire [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]
  • Other PROMs [Срок оценки: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)]

Критерии участия

PURPOSE 1:

Inclusion criteria for surgery participants:

  • Persons who will soon undergo surgery on the vocal folds and/or larynx (including glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty) at UZ Gent
  • At least 18 years old
  • Sufficient command of the Dutch language for understanding the informed consent letter and completing Dutch questionnaires

Inclusion criteria for volunteers to provide speech samples:

\- Cisgender men or women

Inclusion criteria for volunteer listeners for the listening experiment:

  • Dutch-speaking
  • Self-reported normal hearing

PURPOSE 2: same as above.

PURPOSE 3:

Inclusion criteria for the healthy participants:

  • At least 18 years old
  • Sufficient command of the Dutch language to complete a Dutch questionnaire

Exclusion criteria for the healthy participants:

\- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).

Inclusion criteria for the pre- and postoperative MRI participants:

\- Random selection of +- 10 participants of purpose 1.

Exclusion criteria for the pre- and postoperative MRI participants:

\- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Диагностика

Центры проведения

Бельгия · 2 центра
  • Ghent University Hospital — Ghent
  • Ghent University — Ghent

Идентификаторы

NCT: NCT06439290 · ONZ-2024-0049/ONZ-2024-0081

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗