The Effectiveness of Reconstructive Microsurgery on the Clinical and Functional State of Laryngeal Stenosis

Larynx Disease Clinical Trial

Official title:

The Effectiveness of Reconstructive Microsurgery on the Clinical and Functional State of Laryngeal Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04734483
• Other study ID #: Aliya_Turayeva
• Secondary ID: dr.turayeva
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2021
• Source: Astana Medical University
• Contact: Aliya Turayeva, PhD
• Phone: +77073681054
• Email: cvetalnur[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment.

Description:

The study include patients with laryngeal pathology in the otorhinolaryngology clinic of the 1-city hospital at Nur-Sultan city. All patients cheek up the necessary clinical, functional, diagnostic studies and treatment measures. It is planned to examine and operate on 70 patients with laryngeal pathology. 1. To study the features of the course of stenosis of the larynx under the influence of various factors, as well as traumatic injuries. 2. To develop optimal diagnostic methods for patients with laryngeal stenosis. 3. To assess the effectiveness of endolaryngeal microsurgery in patients with laryngeal stenosis. 4. To develop recommendations for the organization of treatment for stenosis of the larynx with an increase its functional state.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 74 Years

Eligibility

Inclusion Criteria:

• medically diagnosed with stenosis of larynx
• patients who were observed larynx by MRI and CT
• patients who need surgical treatment of stenosis of larynx

Exclusion Criteria:

• pregnancy
• patients who has positive electromyography findings of motion of laryngeal muscles
• patients who has contraindications to surgical treatment on the other diseases
• patients who has not normal results of lab. analyses

Related Conditions & MeSH terms

• Constriction, Pathologic
• Laryngeal Diseases
• Laryngeal Stenosis
• Laryngostenosis
• Larynx Disease

Intervention

Diagnostic Test:
• spirometry
spirometry

Radiation:
• MRI and CT
MRI and CT

Other:
• Laryngoscopy
laryngoscopy
• electromyography
electromyography

Locations

Country	Name	City	State
Kazakhstan	Astana Medical University	Astana
Russian Federation	Saint-Petersburg Research Institute of Ear, Throat, Nose and Speech	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Astana Medical University

Countries where clinical trial is conducted

Kazakhstan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline forced expiratory volume	Spirometry	at baseline and at 24-week postrandomization
Primary	Change from baseline area between vocal cords	MRI and CT of larynx	at baseline and at 24-week postrandomization
Primary	Change from basiline vocal fold vibration	Laryngoscopy and stroboscopy	at baseline and at 24-week postrandomization
Primary	Evaluate the motor system by recording action potential generated in muscle fibres like thyroarytenoid, lateral cricoarytenoid, posterior cricoarytenoid, interarytenoid, cricothyroid.	Electromyography	at baseline