Clinical trial NCT06439290: Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty
Official title: Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Larynx
Transgenderism
Gender Dysphoria
Keywords: Transgender
Phonosurgery
Determinants
MRI
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Purpose 1: prospective non-randomized controlled trial. Experimental group: persons undergoing phonosurgery Control group: age-matched PFAB/PMAB undergoing mastectomy/breast augmentation

Purpose 2: Predictors of the outcome of abovementioned surgery in the experimental group will be determined using correlational research (regression analysis).

Purpose 3: After optimization of MRI sequences and testing in healthy participants (n=5), a segmentation and measurement workflow will be completed. Objective measurement of pre- and postoperative laryngeal anatomy: Anatomical outcome measures will be obtained and compared before and one month/6 months after surgery in the experimental group.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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).

Primary outcomes:
measure: Speaking fo
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
measure: FF 1-5
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
measure: Perceptual femininity/masculinity score
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Secondary outcomes:
measure: Vocal capacity
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
measure: Vocal range
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
measure: Vocal quality
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
measure: Laryngeal function
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
measure: PROMs: Voice Handicap Index
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
measure: PROMs: Trans Woman Voice Questionnaire
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
measure: Other PROMs
timeFrame: pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East-Flanders
city: Ghent
country: Belgium
facility: Ghent University
state: East-Flanders
Study officials:
affiliation: University Ghent
name: Clara Leyns, PhD
role: STUDY_DIRECTOR
affiliation: University Ghent
name: Evelien D'haeseleer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Peter Tomassen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: