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

NCT06439290 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2024-06-03

No results posted yet for this study

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.

Conditions

  • Surgery
  • Larynx
  • Transgenderism
  • Gender Dysphoria

Interventions

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.

PROCEDURE

Mastectomy/breast augmentation

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

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Clara Leyns, PhD · University Ghent

  • Evelien D'haeseleer, PhD · University Ghent

  • Peter Tomassen, PhD, MD · University Hospital, Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439290 on ClinicalTrials.gov