Evaluating voice outcomes after gender-affirming voice surgeries
Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty
This study is testing how different gender-affirming voice surgeries affect voice quality and patient satisfaction over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Ghent Academic / other |
| Locations | 2 sites (Ghent, East-Flanders and 1 other locations) |
| Trial ID | NCT06439290 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the short- and long-term voice outcomes of various gender-affirming surgeries, including glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty. It employs a prospective non-randomized controlled trial design and utilizes a multidimensional voice assessment protocol. Additionally, a laryngeal MRI protocol will be developed to analyze pre- and postoperative anatomical factors and their correlation with acoustic changes in voice. The study will also evaluate the impact of these surgeries on voice characteristics, psychosocial well-being, and patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who are scheduled to undergo voice-related surgeries at UZ Gent and have a sufficient command of the Dutch language.
Not a fit: Patients who do not speak Dutch or have contraindications for MRI examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of voice outcomes for transgender and gender-diverse individuals undergoing voice surgeries, leading to improved surgical techniques and patient satisfaction.
How similar studies have performed: While there have been studies on voice outcomes in transgender individuals, this specific combination of interventions and methodologies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Ghent, East-Flanders and 1 other locations
- Ghent University Hospital — Ghent, East-Flanders, Belgium (Recruiting)
- Ghent University — Ghent, East-Flanders, Belgium (Recruiting)
Study contacts
- Principal investigator: Evelien D'haeseleer, PhD — University Ghent
- Study coordinator: Evelien D'haeseleer, PhD
- Email: evelien.dhaeseleer@ugent.be
- Phone: +32 9 332 24 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.