Simultaneous Operations on the Thyroid Gland and Hyoid Suspension in Patients With Combined Thyroid Pathology and OSA

NCT05033626 | Unknown

• 1 other identifier: NMSC-02-21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea; Obstructive Sleep Apnea-hypopnea; Obstructive Sleep Apnea-hypopnea Syndrome

Keywords

OSA, CPAP, hyoid suspension, hypopharyngeal obstruction

Outcome Measures

Primary Outcomes (1)

• The absence of severe adverse reactions

  Shortness of breath, bleeding, suppuration

  Up to 2 months after surgery

Secondary Outcomes (10)

• The STOP-BANG questionnaire

  Screening, Day 30 and Day 60

• Three-level European quality of life five-dimensional questionnaire

  Screening, Day 30 and Day 60

• Apnea-Hypopnea Index (AHI)

  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

Study Arms (2)

Thyroidectomy

OTHER

Procedure: Thyroidectomy

Simultaneous thyroidectomy and hyoid suspension

EXPERIMENTAL

Procedure: Simultaneous thyroidectomy and hyoid suspension; Procedure: Thyroidectomy

Interventions

Simultaneous thyroidectomy and hyoid suspension PROCEDURE

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.

Simultaneous thyroidectomy and hyoid suspension

Thyroidectomy PROCEDURE

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.

Simultaneous thyroidectomy and hyoid suspension; Thyroidectomy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia: lead

Study Sites (1)

Pirogov National Medical and Surgical Center

Moscow, 105203, Russia

RECRUITING

Related Publications (3)

• 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.

  PMID: 26801005 RESULT

• 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.

  PMID: 23509464 RESULT

• 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.

  PMID: 16647548 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Microcephaly, Primary Autosomal Recessive, 6

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Oleg Savchuk, MD

  Pirogov National Medical and Surgical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oleg Savchuk, MD, PhD

CONTACT

+79175728719; osavchuk71@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor, Principal Investigator

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: October 15, 2021
• Primary Completion: October 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after completion of the study
• Access Criteria: upon the request

Locations

RU (1)