Clinical trial NCT05033626: Simultaneous Operations on the Thyroid Gland and Hyoid Suspension in Patients With Combined Thyroid Pathology and OSA
Official title: Simultaneous Operations on the Thyroid Gland and Hyoid Suspension in Patients With Combined Thyroid Pathology and Obstructive Sleep Apnea (OSA).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Obstructive Sleep Apnea-hypopnea
Obstructive Sleep Apnea-hypopnea Syndrome
Keywords: OSA, CPAP, hyoid suspension, hypopharyngeal obstruction
Lead sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 10
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* The patient understands the essence of all procedures planned in the framework of an initiative clinical trial and voluntarily confirms his desire to participate by written informed consent;
* Male or female patients with completed skeletal growth at the age of 30 to 60 years, inclusively, with thyroid pathology and moderate to severe OSAS according to cardiorespiratory monitoring with obstruction of the soft tissues of the upper respiratory tract at the levels of the oropharyngeal and laryngopharynx, without radiography of the pathology of the paranasal sinuses;
* Еhe patient is scheduled for thyroid gland surgery (thyroidectomy with / without lymphadenectomy, subtotal resection of the thyroid gland, hemithyroidectomy).

Exclusion Criteria:

* Women during pregnancy, childbirth;
* Women during breastfeeding;
* Persons with mental disorders;
* Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest;
* Chronic somatic diseases in the stage of decompensation. Conditions and concomitant pathology of other organs, which are a contraindication for general anesthesia and intubation;
* Diseases and conditions associated with severe bleeding disorders (hemophilia, von Willebrand disease, deficiency of one or more coagulation factors, etc.);
* Infectious diseases in the acute stage.
* Severe brain injuries, which entailed consequences in the form of focal epilepsy, encephalopathy, dementia;
* Pathology of the paranasal sinuses according to X-ray data;
* Pathologies that are relative contraindications for CPAP therapy (bullous lung disease; pulmonary emphysema; a history of pneumothorax, pneumomediastinum, pneumocephalus, respiratory distress syndrome, external liquorrhea; previous surgical interventions on the brain, middle or inner ear, pituitary gland; recurrent sinusitis; recurrent eye infections; severe hypotension; severe dehydration; frequent nosebleeds; fractures of the bones of the face; condition after esophagectomy in history (risk of damage to the anastomosis due to increased pharyngeal / esophageal pressure); hemodynamic instability; a history of severe chronic heart failure; Decompensation of major diseases; cardiomyopathy of any genesis; oncological diseases (except for pathology of the thyroid gland);
* Pathologies that are absolute contraindications for CPAP therapy (unconsciousness of the patient; severe respiratory failure, which may require intubation and subsequent mechanical ventilation; cerebrospinal fluid fistula; collapse of the epiglottis according to sleep endoscopy);
* refusal of the patient to carry out CPAP therapy.

Primary outcomes:
measure: The absence of severe adverse reactions
timeFrame: Up to 2 months after surgery
Secondary outcomes:
measure: The STOP-BANG questionnaire
timeFrame: Screening, Day 30 and Day 60
measure: Three-level European quality of life five-dimensional questionnaire
timeFrame: Screening, Day 30 and Day 60
measure: Apnea-Hypopnea Index (AHI)
timeFrame: Screening, Day 30 and Day 60
measure: The Epworth Sleepiness Scale (ESS)
timeFrame: Screening, Day 30 and Day 60
measure: Pittsburgh Sleep Quality Index (PSQI) Questionnaire
timeFrame: Screening, Day 30 and Day 60
measure: Cardiorespiratory monitoring
timeFrame: Screening, Day 60
measure: Native endoscopy of the upper respiratory tract with Müller's test
timeFrame: Screening, Day 30 and Day 60
measure: Sleep endoscopy
timeFrame: Screening, Day 60
measure: The intensity of pain assesment
timeFrame: On the day of surgery, 2 days after the surgery
measure: Pulse oximetry
timeFrame: On the day of surgery, 2 days after the surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov National Medical and Surgical Center
Study officials:
affiliation: Pirogov National Medical and Surgical Center
name: Oleg Savchuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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: 10.1155/2013/263043. Epub 2013 Feb 20.
citation: 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.