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Clinical Trial Summary

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


Clinical Trial Description

The ineffectiveness of conservative treatment of obstructive sleep apnea syndrome (OSAS) (CPAP-therapy) or its rejection leads to a surgical solution of the issue, the purpose of which is to eliminate obvious anatomical obstacles, to increase the lumen of the upper respiratory tract. Modern methods of multilevel surgical treatment of OSAS make it possible to achieve more than 80% success. Most often, at the first stage of OSAS treatment, otorhinolaryngologists use rhinosurgical techniques such as septoplasty, lower submucosal vasotomy, partial conchotomy, removal of nasal polyps, including using endoscopic techniques. At the subsequent stages of multilevel treatment, depending on the level of obstruction and the severity of OSAS, uvulopalatoplasty or uvulopalatopharyngoplasty, partial resection of the tongue or lingual tonsil, suspension of the tongue root and sublingual system, various types of genioplasty and maxillary reduction are performed. This approach allows expanding the airways in the oropharyngeal region and laryngopharynx, improving functional outcomes and quality of life in patients with OSAS. At the same time, first of all, it is necessary to carefully assess the benefits and potential risks of surgical treatment, especially in patients with an unfavorable morbid background and from older age groups. • The investigators will offer patients with concomitant thyroid pathology and moderate or severe OSAS to perform simultaneous operations from one access, where the hyoid bone to the thyroid cartilage will be sutured in the second stage. The stabilization of the hyoid bone and the muscular frame, as an integral complex of the laryngopharynx, increases the airway space and neutralizes obstruction. (1-3) Under endotracheal anesthesia, a horizontal skin incision up to 5 cm long is made at the level of the upper edge of the 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. The vessels of the upper and lower poles are separated with the preservation of blood supply to the right and left upper and lower parathyroid glands. Using a microsurgical technique, neurolysis of the recurrent laryngeal nerves is performed. The control of the integrity of the recurrent laryngeal nerves was performed using the neuromonitoring apparatus. 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. Advantages: - access from one incision with combined pathology of the thyroid gland and OSAS which reduces the need for delayed operations; - decrease in apnea hypopnea index (AHI) to 50.7% and subjective daytime sleepiness according to foreign literature. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05033626
Study type Interventional
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 [email protected]
Status Not yet recruiting
Phase N/A
Start date October 1, 2021
Completion date November 1, 2022

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