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

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

Detailed Description
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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. To study the features of the course of stenosis of the larynx under the influence of various factors, as well as traumatic injuries. To develop optimal diagnostic methods for patients with laryngeal stenosis. To assess the effectiveness of endolaryngeal microsurgery in patients with laryngeal stenosis. To develop recommendations for the organization of treatment for stenosis of the larynx with an increase its functional state.

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

Conditions
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Larynx Disease, Laryngeal Stenosis

Intervention / Treatment
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* Diagnostic Test: spirometry
* Radiation: MRI and CT
* Other: Laryngoscopy
* Other: electromyography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment, prospective, single-center
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: functional findings<br>Participants with laryngeal stenosis | Diagnostic Test: spirometry<br>* spirometry<br>|
| Active Comparator: to find anatomic feathers of larynx<br>Participants with laryngeal stenosis | Radiation: MRI and CT<br>* MRI and CT<br>Other: Laryngoscopy<br>* laryngoscopy<br>|
| Active Comparator: to determine the type of stenosis of larynx and method of surgical treatment<br>Participants with laryngeal stenosis | Diagnostic Test: spirometry<br>* spirometry<br>Radiation: MRI and CT<br>* MRI and CT<br>Other: Laryngoscopy<br>* laryngoscopy<br>Other: electromyography<br>* electromyography<br>|
| Active Comparator: determining the motor abilities of the muscles of the larynx<br>Participants with laryngeal stenosis | Other: electromyography<br>* electromyography<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal stenosis, laryngeal MRI, laryngeal CT, pulmonary test, laryngoscopy