Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-27 @ 6:52 AM
Study NCT ID:
NCT06161467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Laryngeal Ultrasound as an Alternative to Direct Flexible Laryngoscopy in Assessment of Vocal Cords
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Transcutaneous Laryngeal Ultrasoungraphy (TLUS) as an Alternative to Direct Flexible Laryngoscopy (DFL) in Assessment of Vocal Cords Appearance in Patients Underwent Thyroid Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy
Detailed Description:
Thyroid and parathyroid surgery are the most common procedures in endocrine surgery worldwide. They are mainly associated with two major complications: recurrent laryngeal nerve (RLN) palsy and hypoparathyroidism, The preservation of recurrent laryngeal nerve (RLN) is an essential part of thyroid surgery {1}. The various methods to test the normal functionality of vocal cords (VCs) include direct visualisation under the fiber bronchoscope, indirect laryngoscopy, laryngeal muscles electromyography, computed tomography (CT), and magnetic resonance imaging (MRI). We aimed to assess the usefulness of ultrasound (USG) in the examination of VC morphology and movement.
Recurrent laryngeal nerve injury ranges from 1.4 to 5.1% following surgery involving the thyroid gland.
Otolaryngology and Head and Neck Surgery suggested that all patients undergoing thyroid and parathyroid procedures should undergo routinely preoperative and postoperative DFL \[6\].
Laryngoscopy is considered the golden standard to evaluate vocal fold mobility preoperatively. As it can demonstrate a paralysis of the recurrent laryngeal nerve,. Yet it is not common practice for many endocrine surgery teams because it is time consuming, imposes extra costs, and is in general, an unpleasant experience for some patients.{2} head and neck ultrasonography is a cost effective imaging tool that is currently used as an extension of patient physical examination. That is based on its safety (non invasive and non ionizing radiation dependent), repeatability, availability and good patient compliance (pain less and require no sedation). {3} recently portable ultrasound devices became widely available with dramatic improvement of the imaging quality rendering to increased diagnostic accuracy. Availability, usability and mobility of the devices encourage bedside examination which is essential in non mobile patient and ICU patient \[4\] .
However, the experience is limited and the reliability of the TLUS in thyroid and parathyroid surgery is still being debated
Recurrent laryngeal nerve injury ranges from 1.4 to 5.1% following surgery involving the thyroid gland.
Otolaryngology and Head and Neck Surgery suggested that all patients undergoing thyroid and parathyroid procedures should undergo routinely preoperative and postoperative DFL \[6\].
Laryngoscopy is considered the golden standard to evaluate vocal fold mobility preoperatively. As it can demonstrate a paralysis of the recurrent laryngeal nerve,. Yet it is not common practice for many endocrine surgery teams because it is time consuming, imposes extra costs, and is in general, an unpleasant experience for some patients.{2} head and neck ultrasonography is a cost effective imaging tool that is currently used as an extension of patient physical examination. That is based on its safety (non invasive and non ionizing radiation dependent), repeatability, availability and good patient compliance (pain less and require no sedation). {3} recently portable ultrasound devices became widely available with dramatic improvement of the imaging quality rendering to increased diagnostic accuracy. Availability, usability and mobility of the devices encourage bedside examination which is essential in non mobile patient and ICU patient \[4\] .
However, the experience is limited and the reliability of the TLUS in thyroid and parathyroid surgery is still being debated
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: