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

Astana Medical University70 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Larynx Disease Laryngeal Stenosis

Interventions

spirometryDIAGNOSTIC_TEST

spirometry

MRI and CTRADIATION

MRI and CT

LaryngoscopyOTHER

laryngoscopy

electromyography

Eligibility

Sex: ALLMin age: 1 YearMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Astana Medical University

Astana, Kazakhstan

RECRUITING

Saint-Petersburg Research Institute of Ear, Throat, Nose and Speech

Saint Petersburg, Russia

RECRUITING

Outcomes

Primary Outcomes

Change from baseline forced expiratory volume

Spirometry

Time frame: at baseline and at 24-week postrandomization

Change from baseline area between vocal cords

MRI and CT of larynx

Time frame: at baseline and at 24-week postrandomization

Change from basiline vocal fold vibration

Laryngoscopy and stroboscopy

Time frame: 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

Time frame: at baseline

Central Contacts

Aliya Turayeva, PhD

CONTACT

+77073681054 cvetalnur@mail.ru

Data from ClinicalTrials.gov

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