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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Belgium
Ghent University
RECRUITING
Ghent
Ghent University Hospital
RECRUITING
Ghent
Contact Information
Primary
Evelien D'haeseleer, PhD
evelien.dhaeseleer@ugent.be
+32 9 332 24 67
Backup
Clara Leyns, PhD
clara.leyns@ugent.be
+3293320143
Time Frame
Start Date: 2024-04-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 290
Treatments
Experimental: Experimental group: phonosurgery
Group undergoing phonosurgery (glottoplasty, cricothyroid approximation, thyroplasty or chondrolaryngoplasty)
Active_comparator: Control group: other surgery
Control group: age matched TGD PFAB/PMAB undergoing mastectomy or breast augmentation surgery with the same in- and exclusion criteria.
Related Therapeutic Areas
Sponsors
Leads: University Ghent

This content was sourced from clinicaltrials.gov