Evaluating voice outcomes after gender-affirming voice surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.