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Recruiting NCT06439290

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

No phase Interventional Surgery Larynx Transgenderism Gender Dysphoria

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phonosurgery, Mastectomy/breast augmentation.
Who it may be relevant to
Registry conditions: Surgery, Larynx, Transgenderism, Gender Dysphoria. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Procedure 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
  • Procedure Mastectomy/breast augmentation
    Control group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery.

Primary outcome measures

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

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Belgium · 2 centers
  • Ghent University Hospital — Ghent
  • Ghent University — Ghent

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗