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

Primary Purpose

Larynx Disease, Laryngeal Stenosis

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

spirometry

MRI and CT

Laryngoscopy

electromyography

About this trial

This is an interventional treatment trial for Larynx Disease focused on measuring laryngeal stenosis, laryngeal MRI, laryngeal CT, pulmonary test, laryngoscopy

Eligibility Criteria

1 Year - 74 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Astana Medical UniversityRecruiting
Saint-Petersburg Research Institute of Ear, Throat, Nose and SpeechRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

functional findings

to find anatomic feathers of larynx

to determine the type of stenosis of larynx and method of surgical treatment

determining the motor abilities of the muscles of the larynx

Arm Description

Participants with laryngeal stenosis

Outcomes

Primary Outcome Measures

Change from baseline forced expiratory volume

Spirometry

Change from baseline area between vocal cords

MRI and CT of larynx

Change from basiline vocal fold vibration

Laryngoscopy and stroboscopy

Evaluate the motor system by recording action potential generated in muscle fibres like thyroarytenoid, lateral cricoarytenoid, posterior cricoarytenoid, interarytenoid, cricothyroid.

Electromyography

Secondary Outcome Measures

Full Information

NCT ID

NCT04734483

First Posted

December 3, 2020

Last Updated

January 29, 2021

Sponsor

Astana Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04734483

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

May 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astana Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Larynx Disease, Laryngeal Stenosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment, prospective, single-center

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

functional findings

Arm Type

Active Comparator

Arm Description

Participants with laryngeal stenosis

Arm Title

to find anatomic feathers of larynx

Arm Type

Active Comparator

Arm Description

Participants with laryngeal stenosis

Arm Title

to determine the type of stenosis of larynx and method of surgical treatment

Arm Type

Active Comparator

Arm Description

Participants with laryngeal stenosis

Arm Title

determining the motor abilities of the muscles of the larynx

Arm Type

Active Comparator

Arm Description

Participants with laryngeal stenosis

Intervention Type

Diagnostic Test

Intervention Name(s)

spirometry

Intervention Description

spirometry

Intervention Type

Radiation

Intervention Name(s)

MRI and CT

Intervention Description

MRI and CT

Intervention Type

Other

Intervention Name(s)

Laryngoscopy

Intervention Description

laryngoscopy

Intervention Type

Other

Intervention Name(s)

electromyography

Intervention Description

electromyography

Primary Outcome Measure Information:

Title

Change from baseline forced expiratory volume

Description

Spirometry

Time Frame

at baseline and at 24-week postrandomization

Title

Change from baseline area between vocal cords

Description

MRI and CT of larynx

Time Frame

at baseline and at 24-week postrandomization

Title

Change from basiline vocal fold vibration

Description

Laryngoscopy and stroboscopy

Time Frame

at baseline and at 24-week postrandomization

Title

Evaluate the motor system by recording action potential generated in muscle fibres like thyroarytenoid, lateral cricoarytenoid, posterior cricoarytenoid, interarytenoid, cricothyroid.

Description

Electromyography

Time Frame

at baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aliya Turayeva, PhD

Phone

+77073681054

cvetalnur@mail.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aliya Turayeva, PhD

Organizational Affiliation

Astana Medical Academy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Astana Medical University

City

Astana

ZIP/Postal Code

010000

Country

Kazakhstan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rais Tulebaev, Professor

Phone

+77017104509

rais007@rambler.ru

First Name & Middle Initial & Last Name & Degree

Aliya Turayeva, PhD

Phone

+77073681054

cvetalnur@mail.ru

First Name & Middle Initial & Last Name & Degree

Amanjol Baymenov, Docent

Facility Name

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

City

Saint Petersburg

ZIP/Postal Code

190013

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sergey Karpischenko, Prifessor

Phone

+7911717-62-26

karpischenkos@mail.ru

12. IPD Sharing Statement

Learn more about this trial

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

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