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

January 29, 2021 updated by: Astana Medical University
To improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Recruiting
        • Astana Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Amanjol Baymenov, Docent
  • Russian Federation
      • Saint Petersburg, Russian Federation, 190013
        • Recruiting
        • Saint-Petersburg Research Institute of Ear, Throat, Nose and Speech
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 74 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline forced expiratory volume
Time Frame: at baseline and at 24-week postrandomization
Spirometry
at baseline and at 24-week postrandomization
Change from baseline area between vocal cords
Time Frame: at baseline and at 24-week postrandomization
MRI and CT of larynx
at baseline and at 24-week postrandomization
Change from basiline vocal fold vibration
Time Frame: at baseline and at 24-week postrandomization
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.
Time Frame: at baseline
Electromyography
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astana Medical University

Investigators

  • Principal Investigator: Aliya Turayeva, PhD, Astana Medical Academy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aliya_Turayeva
  • dr.turayeva (Registry Identifier: Aliya Turayeva)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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