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

NCT ID: NCT04734483

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Larynx Disease Laryngeal Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment, prospective, single-center
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

functional findings

Participants with laryngeal stenosis

Group Type ACTIVE_COMPARATOR

spirometry

Intervention Type DIAGNOSTIC_TEST

spirometry

to find anatomic feathers of larynx

Participants with laryngeal stenosis

Group Type ACTIVE_COMPARATOR

MRI and CT

Intervention Type RADIATION

MRI and CT

Laryngoscopy

Intervention Type OTHER

laryngoscopy

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

Participants with laryngeal stenosis

Group Type ACTIVE_COMPARATOR

spirometry

Intervention Type DIAGNOSTIC_TEST

spirometry

MRI and CT

Intervention Type RADIATION

MRI and CT

Laryngoscopy

Intervention Type OTHER

laryngoscopy

electromyography

Intervention Type OTHER

electromyography

determining the motor abilities of the muscles of the larynx

Participants with laryngeal stenosis

Group Type ACTIVE_COMPARATOR

electromyography

Intervention Type OTHER

electromyography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

spirometry

spirometry

Intervention Type DIAGNOSTIC_TEST

MRI and CT

MRI and CT

Intervention Type RADIATION

Laryngoscopy

laryngoscopy

Intervention Type OTHER

electromyography

electromyography

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astana Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aliya Turayeva, PhD

Role: PRINCIPAL_INVESTIGATOR

Astana Medical Academy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Astana Medical University

Astana, , Kazakhstan

Site Status RECRUITING

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

Saint Petersburg, , Russia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Kazakhstan Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aliya Turayeva, PhD

Role: CONTACT

+77073681054

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rais Tulebaev, Professor

Role: primary

+77017104509

Aliya Turayeva, PhD

Role: backup

+77073681054

Sergey Karpischenko, Prifessor

Role: primary

+7911717-62-26

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

dr.turayeva

Identifier Type: REGISTRY

Identifier Source: secondary_id

Aliya_Turayeva

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non-invasive Markers of Esophageal Function in Adults
NCT04074356 ENROLLING_BY_INVITATION NA