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

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria; Surgery; Larynx; Transgenderism
• Intervention / Treatment: Procedure: Phonosurgery; Procedure: Mastectomy/breast augmentation

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.

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelien D'haeseleer, PhD; Phone Number: +32 9 332 24 67; Email: evelien.dhaeseleer@ugent.be
• Study Contact Backup: Name: Clara Leyns, PhD; Phone Number: +3293320143; Email: clara.leyns@ugent.be

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • Recruiting
      • Ghent University
      • Contact: Clara Leyns, PhD; Email: clara.leyns@ugent.be
    • Ghent, East-Flanders, Belgium, 9000
      • Recruiting
      • Ghent University Hospital
      • Contact: Clara Leyns, PhD; Email: clara.leyns@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group: phonosurgery; Group undergoing phonosurgery (glottoplasty, cricothyroid approximation, thyroplasty or chondrolaryngoplasty)	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 further investigated.; Other Names: glottoplasty; thyroplasty; cricothyroid approximation; chondrolaryngoplasty
Active Comparator: Control group: other surgery; Control group: age matched TGD PFAB/PMAB undergoing mastectomy or breast augmentation surgery with the same in- and exclusion criteria.	Procedure: Mastectomy/breast augmentation; Control group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speaking fo	Speaking fundamental frequency	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
FF 1-5	Formant frequencies 1-5	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Perceptual femininity/masculinity score	Self-perception and listener perceptions of femininity and masculinity. Visual analogue scale (0 = very masculine, 100 = very feminine).	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vocal capacity	Dysphonia Severity Index, cut-off score 1.6 (above 1.6 is normophonic)	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Vocal range	Voice Range Profile (min-max of fo and intensity (SPL))	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Vocal quality	Acoustic Voice Quality Index, cut-off score 2.95 (below 2.95 is normophonic)	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Laryngeal function	Flexible videolaryngostroboscopy	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
PROMs: Voice Handicap Index	Voice Handicap Index, score from 0-120, the higher the score, the worse.	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
PROMs: Trans Woman Voice Questionnaire	Trans Woman Voice Questionnaire, score from 1-120, the higher the score, the worse.	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)
Other PROMs	Visual analogue scales to measure satisfaction (VAS with 0=strongly disagree, 100=strongly agree).	pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Evelien D'haeseleer, PhD, University Ghent; Study Director: Clara Leyns, PhD, University Ghent; Principal Investigator: Peter Tomassen, PhD, MD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Determinants; Transgender; Phonosurgery
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: ONZ-2024-0049/ONZ-2024-0081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No