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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04734483
Enrollment
70
Registered
2021-02-02
Start date
2019-05-01
Completion date
2021-06-01
Last updated
2021-02-02

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

Conditions

Laryngeal Stenosis, Larynx Disease

Keywords

laryngeal stenosis, laryngeal MRI, laryngeal CT, pulmonary test, laryngoscopy

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.

Interventions

DIAGNOSTIC_TESTspirometry

spirometry

RADIATIONMRI and CT

MRI and CT

OTHERLaryngoscopy

laryngoscopy

OTHERelectromyography

electromyography

Sponsors

Astana Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Parallel Assignment, prospective, single-center

Eligibility

Sex/Gender
ALL
Age
1 Years to 74 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline forced expiratory volumeat baseline and at 24-week postrandomizationSpirometry
Change from baseline area between vocal cordsat baseline and at 24-week postrandomizationMRI and CT of larynx
Change from basiline vocal fold vibrationat baseline and at 24-week postrandomizationLaryngoscopy and stroboscopy
Evaluate the motor system by recording action potential generated in muscle fibres like thyroarytenoid, lateral cricoarytenoid, posterior cricoarytenoid, interarytenoid, cricothyroid.at baselineElectromyography

Countries

Kazakhstan, Russia

Contacts

Primary ContactAliya Turayeva, PhD
cvetalnur@mail.ru+77073681054

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026