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Evaluation the effect of endoscopic medialization thyroplasty using nasal septal cartilage graft on voice features

Evaluation the effect of endoscopic medialization thyroplasty using autologous nasal septal cartilage graft in patients with unilateral vocal fold paralysis on voice features: A before and after clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231003059595N1
Enrollment
15
Registered
2023-11-11
Start date
2023-11-11
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paralysis of vocal cords and larynx. Paralysis of vocal cords and larynx, unspecified

Interventions

In operating room conditions and under general anesthesia, after prep and drape in sterile conditions, a hemitransfix incision is made at the mucocutaneous junction to remove the septum. The mucoperic

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Unilateral vocal fold paralysis Age : above 18y

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study Saddle nose Bilateral vocal fold paralysis History of septoplasty Uncontrolled head and neck malignancy External laryngeal trauma Laryngeal neoplasm Severe laryngeal stenosis Central nervous system disorder Severe cardiopulmonary disorder that the patient cannot tolerate surgery

Design outcomes

Primary

MeasureTime frame
Stridor. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient.;Aspiration. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient.;Auditory-perceptual characteristics of sound. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: GRBAS scale is used to evaluate audio-perception of sound, which describes Grade, Roughness, Breathiness, Asthenia and Straining in 4 modes (0=no defect, 1=mild defect, 2=moderate defect and 3=severe defect). This index is an expert-oriented index. For this purpose, the voice sample recorded from the patient with the help of headphones for the speech therapist is played according to the mentioned 4-degree scale.;Voice handicap index. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Questionnaire will be filled in three functional, physical and emotional parts in these patients. This questionnaire has 30 questions, and it is provided to the patient and completed by them in each of the assessment phases.;Acoustic characteristics of sound. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Acoustic evaluations include many things that are evaluated in this research. All acoustic evaluations will be done by a speech therapist with the help of PRAAT software. The types of acoustic features are mentioned below. 1- Maximum vocalization time (MPT): to evaluate the maximum ability of a person. It is measured based on seconds using a stopwatch in three times and the average number of times is recorded. 2- Jitter: disturbance of frequency and amplitude of frequency disturbance 3- Shimmer: disturbance of amplitude of oscillation 4- Noise to harmonic ratio (NHR): to che

Secondary

MeasureTime frame
Dyspnea. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Based on patient history and clinical presentation using NYHA criteria.;Saddle nose. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient.;Septal perforation. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient.;Surgical site infection. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient.;Chondral graft failure. Timepoint: Before surgery and at intervals of 2 weeks, 2 months, and 6 months after surgery. Method of measurement: Clinical examination of the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Khadivi

Mashhad University of Medical Sciences

khadivie@mums.ac.ir00 51 38400001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026