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Not yet recruitingNCT06161467Updated Dec 8, 2023

Transcutaneous Laryngeal Ultrasound as an Alternative to Direct Flexible Laryngoscopy in Assessment of Vocal Cords

An observational study in Ultrasound Therapy; Complications, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
46
Sex
All
01

Study summary

To evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy

Read the 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

02

Conditions studied

  • Ultrasound Therapy; Complications

Keywords

  • Ultrasound
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients scheduled for thyroid surgery

Inclusion criteria

  • Patients scheduled for thyroid surgery
  • Patients underwent thyroid surgery

Exclusion criteria

Exclusion Criteria:

  • Patients with vocal cord paralysis because of any cause other than thyroid surgery complications
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
46 participants (estimated)
Patient registry
No

Interventions

  • DeviceUltrasound devices

    Safe , no radiation

06

What researchers measure

Primary outcomes

  1. Vocal cords appearance

    Assessment of vocal cords appearance by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)

    Time frame: Two years

  2. Vocal cords movement

    Assessment of vocal cords movement by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)

    Time frame: Two years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer; Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110. Erratum In: Thyroid. 2010 Aug;20(8):942. Hauger, Bryan R [corrected to Haugen, Bryan R]. Thyroid. 2010 Jun;20(6):674-5. PubMed 19860577 ↗
  • Holtel MR. Emerging technology in head and neck ultrasonography. Otolaryngol Clin North Am. 2010 Dec;43(6):1267-74, vii. doi: 10.1016/j.otc.2010.08.003. PubMed 21044741 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06161467
Lead sponsor
Assiut University
Responsible party
Walaa Mohamed Ali sayd (Principal Investigator, Assiut University) — Principal investigator
First posted
Dec 8, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Nov 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Dec 8, 2023

Study contacts

Wala Sayed, Student
Contact
walazidan898@gmail.com
01095876627
Hasan Megaly, Professor
Contact
Hassnibrahim48@yahoo.com
01006209584
Amr Farouk, Professor
principal investigator · Supervisor
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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