Simultaneous Operations on the Thyroid Gland and Hyoid Suspension in Patients With Combined Thyroid Pathology and Obstructive Sleep Apnea (OSA).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The absence of severe adverse reactions
研究概览
简要总结
Simultaneous operations on the thyroid gland and hyoid suspension in patients with combined thyroid pathology and moderate to severe OSA.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
The absence of severe adverse reactions
时间窗: Up to 2 months after surgery
Shortness of breath, bleeding, suppuration
次要结局
- Three-level European quality of life five-dimensional questionnaire(Screening, Day 30 and Day 60)
- The Epworth Sleepiness Scale (ESS)(Screening, Day 30 and Day 60)
- Pittsburgh Sleep Quality Index (PSQI) Questionnaire(Screening, Day 30 and Day 60)
- The STOP-BANG questionnaire(Screening, Day 30 and Day 60)
- Apnea-Hypopnea Index (AHI)(Screening, Day 30 and Day 60)
- Cardiorespiratory monitoring(Screening, Day 60)
- Sleep endoscopy(Screening, Day 60)
- The intensity of pain assesment(On the day of surgery, 2 days after the surgery)
- Pulse oximetry(On the day of surgery, 2 days after the surgery)
- Native endoscopy of the upper respiratory tract with Müller's test(Screening, Day 30 and Day 60)
研究者
Oleg Savchuk
Associated professor, Principal Investigator
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia