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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05033626
Other study ID # NMSC-02-21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2021
Est. completion date May 1, 2024

Study information

Verified date March 2023
Source State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Contact Oleg Savchuk, MD, PhD
Phone +79175728719
Email osavchuk71@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Simultaneous operations on the thyroid gland and hyoid suspension in patients with combined thyroid pathology and moderate to severe OSA.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Simultaneous thyroidectomy and hyoid suspension
Under endotracheal anesthesia, a horizontal skin incision up to 50 mm long is made at the level of the upper thyroid cartilage, the skin and subcutaneous fat are dissected. The sternohyoid and sternothyroid muscles are retracted. An audit of the thyroid gland is performed. Step by step, using the ultrasonic dissector, the sections of the gland necessary for resection are separated, ligated and transected. Using microsurgical techniques, neurolysis of the recurrent laryngeal nerves is performed. The quality control of the return of the laryngeal nerves is ensured to the required extent using the neuromonitoring apparatus.
Thyroidectomy
The hyoid bone is mobilized in the anterocaudal direction and is fixed to the thyroid cartilage with four permanent non-absorbable sutures. If sufficient mobilization does not occur during the operation, the tendon of the stylohyoid muscle is dissected. Surgical drainage is installed 24 hours after surgery.

Locations

Country Name City State
Russian Federation Pirogov National Medical and Surgical Center Moscow

Sponsors (1)

Lead Sponsor Collaborator
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

Baisch A, Maurer JT, Hormann K. The effect of hyoid suspension in a multilevel surgery concept for obstructive sleep apnea. Otolaryngol Head Neck Surg. 2006 May;134(5):856-61. doi: 10.1016/j.otohns.2006.01.015. — View Citation

Canzi P, Berardi A, Tinelli C, Montevecchi F, Pagella F, Vicini C, Benazzo M. Thirteen Years of Hyoid Suspension Experience in Multilevel OSAHS Surgery: The Short-Term Results of a Bicentric Study. Int J Otolaryngol. 2013;2013:263043. doi: 10.1155/2013/26 — View Citation

Song SA, Wei JM, Buttram J, Tolisano AM, Chang ET, Liu SY, Certal V, Camacho M. Hyoid surgery alone for obstructive sleep apnea: A systematic review and meta-analysis. Laryngoscope. 2016 Jul;126(7):1702-8. doi: 10.1002/lary.25847. Epub 2016 Jan 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The absence of severe adverse reactions Shortness of breath, bleeding, suppuration Up to 2 months after surgery
Secondary The STOP-BANG questionnaire The STOP-BANG questionnaire provides 8 possible signs of the presence of apnea: loud snoring; stopping breathing during sleep; daytime tiredness; increased blood pressure; BMI> 35; neck circumference = 43 cm (41 cm for women), male and over 50 years of age. If there are 3 or more signs, the risk of sleep apnea is considered to be increased. Screening, Day 30 and Day 60
Secondary Three-level European quality of life five-dimensional questionnaire There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Patients choice results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describe the health status. Screening, Day 30 and Day 60
Secondary Apnea-Hypopnea Index (AHI) Apnea-hypopnea index (AHI) is the total number of episodes of complete or partial cessation of breathing during one hour of sleep (with polysomnography or cardiorespiratory monitoring). AHI is used to assess the severity of OSAS. Calculated using the formula: (number of apnea episodes + number of hypopnea episodes) / sleep or study time.
AHI <5 is considered the norm. Average degree of OSAS 15=IAG <30. Severe AHI =30. A decrease in the indicator shows an improvement in OSAS during treatment.
Screening, Day 30 and Day 60
Secondary The Epworth Sleepiness Scale (ESS) The Epworth Sleepiness Scale (ESS) is a scale for measuring daytime sleepiness using a questionnaire. Helpful in diagnosing sleep disorders.
Subjects are asked to rate the likelihood of falling asleep on a scale of increasing probability from 0 to 3 for various situations they encounter in everyday life. The scores for the eight questions are added to form a single number. A number in the range of 0-9 is considered normal, while a number in the range of 10-24 indicates that you should seek professional advice.
Screening, Day 30 and Day 60
Secondary Pittsburgh Sleep Quality Index (PSQI) Questionnaire The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that assesses sleep quality over a 1 month time frame. It consists of 19 individual elements, making up 7 components that give one overall rating. Each item is weighted on a scale from 0 to 3. The overall PSQI score is then calculated by adding the scores of the seven components to give an overall score of 0 to 21, where lower scores mean healthier sleep quality. Screening, Day 30 and Day 60
Secondary Cardiorespiratory monitoring Cardiorespiratory monitoring - is one of the main methods for diagnosing snoring and breathing disorders during sleep. It allows you to identify episodes of snoring and respiratory arrest (apnea) during sleep, to determine the level of oxygen during episodes of disturbed breathing, to reveal the relationship between apnea and disturbances in the rhythm and conduction of the heart, persistent arterial hypertension, and also to establish the degree of OSA Screening, Day 60
Secondary Native endoscopy of the upper respiratory tract with Müller's test Upper airway endoscopy with Müller's test is performed with flexible optics in a sitting or supine position of the patient. After a forced exhalation, he inhales with his hand closed to his nose and mouth. Levels, shapes and severity of nasal, pharyngeal and laryngeal obstruction are assessed Screening, Day 30 and Day 60
Secondary Sleep endoscopy Sleep endoscopy (drug-induced slip endoscopy (DISE)) is a research method in which the patient is immersed in a drug-induced sleep, at a certain depth of which the sound phenomenon of snoring occurs using a flexible endoscope. All parts of the nose, pharynx and larynx are examined. The degree, shape, and levels of obstruction are determined. Screening, Day 60
Secondary The intensity of pain assesment The intensity of pain is quantified using Verbal Rating Scale. The following scale of verbal assessments is applied: 0 - no pain, 1 point - mild, 2 - moderate, 3 - strong, 4 points - very strong and 5 points - unbearable pain. On the day of surgery, 2 days after the surgery
Secondary Pulse oximetry Pulse oximetry is an indirect method for assessing ventilation. Estimation of the average values of saturation is important for the detection of chronic nocturnal hypoxemia and respiratory failure during sleep. A decrease in average saturation values below 90% indicates severe respiratory failure during sleep. On the day of surgery, 2 days after the surgery
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