RecruitingNot ApplicableNCT06439290

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


Sponsor

University Ghent

Enrollment

290 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria12

  • PURPOSE 1:
  • 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
  • \- Cisgender men or women
  • Dutch-speaking
  • Self-reported normal hearing
  • PURPOSE 2: same as above.
  • PURPOSE 3:
  • At least 18 years old
  • Sufficient command of the Dutch language to complete a Dutch questionnaire
  • \- Random selection of +- 10 participants of purpose 1.

Exclusion Criteria2

  • \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
  • \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).

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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.


Locations(2)

Ghent University Hospital

Ghent, East-Flanders, Belgium

Ghent University

Ghent, East-Flanders, Belgium

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NCT06439290


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