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

NCT06439290 | Recruiting DMC

• 1 other identifier: ONZ-2024-0049/ONZ-2024-0081
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Transgender; Phonosurgery; Determinants; MRI

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Vocal capacity

  pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

• Vocal range

  pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

• Vocal quality

  pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

• Laryngeal function

  pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

• PROMs: Voice Handicap Index

  pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year)

Study Arms (2)

Experimental group: phonosurgery

EXPERIMENTAL

Group undergoing phonosurgery (glottoplasty, cricothyroid approximation, thyroplasty or chondrolaryngoplasty)

Procedure: Phonosurgery

Control group: other surgery

ACTIVE COMPARATOR

Control group: age matched TGD PFAB/PMAB undergoing mastectomy or breast augmentation surgery with the same in- and exclusion criteria.

Procedure: Mastectomy/breast augmentation

Interventions

Phonosurgery PROCEDURE

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.

Also known as: glottoplasty, thyroplasty, cricothyroid approximation, chondrolaryngoplasty

Experimental group: phonosurgery

Mastectomy/breast augmentation PROCEDURE

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

Control group: other surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Persons with both a masculine/feminine/nonbinary gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).
• \- Random selection of +- 10 participants of purpose 1.
• \- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).

Sponsors & Collaborators

• University Ghent: lead

Study Sites (2)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Ghent University

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Laryngeal Diseases; Transsexualism; Gender Dysphoria

Interventions

Laryngoplasty; Mastectomy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Sexuality; Sexual Behavior; Behavior; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Clara Leyns, PhD

  University Ghent

  STUDY DIRECTOR

• Evelien D'haeseleer, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Peter Tomassen, PhD, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelien D'haeseleer, PhD

CONTACT

+32 9 332 24 67; evelien.dhaeseleer@ugent.be

Clara Leyns, PhD

CONTACT

+3293320143; clara.leyns@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Assessments will be performed by an ENT specialist and SLP of the research group who is blinded to study evolution and group allocation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Purpose 1: prospective non-randomized controlled trial. Experimental group: persons undergoing phonosurgery Control group: age-matched PFAB/PMAB undergoing mastectomy/breast augmentation Purpose 2: Predictors of the outcome of abovementioned surgery in the experimental group will be determined using correlational research (regression analysis). Purpose 3: After optimization of MRI sequences and testing in healthy participants (n=5), a segmentation and measurement workflow will be completed. Objective measurement of pre- and postoperative laryngeal anatomy: Anatomical outcome measures will be obtained and compared before and one month/6 months after surgery in the experimental group.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 3, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)