Ultrasound Therapy; ComplicationsNCT06161467
Transcutaneous Laryngeal Ultrasound as an Alternative to Direct Flexible Laryngoscopy in Assessment of Vocal Cords
An observational study of Ultrasound Therapy; Complications, run by Assiut University.
Trial summary
To evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- Ultrasound devices
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients scheduled for thyroid surgery
Who may be able to join
- Patients scheduled for thyroid surgery
- Patients underwent thyroid surgery
Who cannot join
- Patients with vocal cord paralysis because of any cause other than thyroid surgery complications
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- Ultrasound devices
- Keywords
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound devicesDevice
Safe , no radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal cords appearance
Assessment of vocal cords appearance by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)
Measured: Two years
Vocal cords movement
Assessment of vocal cords movement by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Mohamed Ali sayd, Assiut University
- Investigators
- Amr Farouk, Professor, Principal investigator, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161467
- Sponsor's protocol ID
- vocal cords in US
- Status last verified
- Dec 2023
- First submitted
- 19 Sep 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
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.
PubMed 19860577Holtel 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06161467
- Acronym / sponsor ID
- vocal cords in US
- Conditions
- Ultrasound Therapy; Complications
- Keywords
- Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled for thyroid surgery
Key inclusion criteria (2 listed)
- Patients scheduled for thyroid surgery
- Patients underwent thyroid surgery
Key exclusion criteria (1 listed)
- Patients with vocal cord paralysis because of any cause other than thyroid surgery complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound devicesSafe , no radiation | Device | – |
Primary outcome
Vocal cords appearance
Time frame: Two years
Assessment of vocal cords appearance by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)
Vocal cords movement
Time frame: Two years
Assessment of vocal cords movement by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 19860577American 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.
- Background: PubMed 21044741Holtel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Farouk, Professor principal investigator
Supervisor
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Therapy; Complications, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wala Sayed, Student (01095876627, walazidan898@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal cords appearance (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06161467, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.