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

Not Applicable

• Conditions: Larynx Disease; Laryngeal Stenosis

• Registration Number: NCT04734483
• Lead Sponsor: Astana Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2020-12-03
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-29
• Last Update Submitted: 2021-01-29
• Study First Posted: 2021-02-02
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (2)

Astana Medical University; 🇰🇿 Astana, Kazakhstan

Saint-Petersburg Research Institute of Ear, Throat, Nose and Speech; 🇷🇺 Saint Petersburg, Russian Federation