Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06439290
Enrollment
290
Registered
2024-06-03
Start date
2024-04-10
Completion date
2027-12-31
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender Dysphoria, Larynx, Surgery, Transgenderism

Keywords

Transgender, Phonosurgery, Determinants, MRI

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.

Interventions

PROCEDUREPhonosurgery

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.

PROCEDUREMastectomy/breast augmentation

Control group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery.

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)

Masking description

Assessments will be performed by an ENT specialist and SLP of the research group who is blinded to study evolution and group allocation.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Speaking fopre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Speaking fundamental frequency
FF 1-5pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Formant frequencies 1-5
Perceptual femininity/masculinity scorepre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Self-perception and listener perceptions of femininity and masculinity. Visual analogue scale (0 = very masculine, 100 = very feminine).

Secondary

MeasureTime frameDescription
Vocal capacitypre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Dysphonia Severity Index, cut-off score 1.6 (above 1.6 is normophonic)
Vocal rangepre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Voice Range Profile (min-max of fo and intensity (SPL))
Vocal qualitypre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Acoustic Voice Quality Index, cut-off score 2.95 (below 2.95 is normophonic)
Laryngeal functionpre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Flexible videolaryngostroboscopy
PROMs: Voice Handicap Indexpre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Voice Handicap Index, score from 0-120, the higher the score, the worse.
PROMs: Trans Woman Voice Questionnairepre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Trans Woman Voice Questionnaire, score from 1-120, the higher the score, the worse.
Other PROMspre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)Visual analogue scales to measure satisfaction (VAS with 0=strongly disagree, 100=strongly agree).

Countries

Belgium

Contacts

Primary ContactEvelien D'haeseleer, PhD
evelien.dhaeseleer@ugent.be+32 9 332 24 67
Backup ContactClara Leyns, PhD
clara.leyns@ugent.be+3293320143

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026