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ThyroidectomyNCT04087447

Dysfunction Following Thyroid Surgery

An observational study of Thyroidectomy, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Voice plays a crucial role in human communication and function. Voice production is multidimensional, involving physiologic, biomechanical, and aerodynamic mechanisms that produce an acoustic output that is perceived by the auditory system. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Thyroidectomy
What is being tested?
Thyroidectomy
Type of treatment
Surgery or procedure
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jan 2020to 1 Jul 2021
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adults patients undergoing thyroid surgery

Who may be able to join

  • benign and malignant thyroid disease normal voice controlled thyroid hormones level

Who cannot join

  • Age below 18 years any cardiac, renal,hepatic, respiratory, mental can interfere with the surgery any voice changes due to any cause before surgery previous head and neck surgery neurological dysfunctions

Trial locations and contacts

No sites are listed yet.

Aya Sharkawy, MBBCH contact

01008137079

Ayasharkawy20@gmail.com

About this study

Official title: Vocal and Swallowing Dysfunction Following Thyroid Surgery

Voice plays a crucial role in human communication and function. Voice production is multidimensional, involving physiologic, biomechanical, and aerodynamic mechanisms that produce an acoustic output that is perceived by the auditory system. So its important to evaluate patients with voice disorders, whenever possible, to characterize the impact of the disorder(s) on all of the pertinent mechanisms/dimensions.

Read the detailed description

Voice changes due to laryngeal dysfunction after thyroid surgery are very common complication. However, very few data in the literatures are available which highlights the impact of thyroidectomy and effects of factors, such as patient age, sex, operation type, surgeons experience, laryngeal nerve injury and orotracheal intubation on voice of patients undergoing thyroid surgery. Prabhat AK et al. 2018 reported that, In majority of cases voice changes are transient. The voice recovery time ranges from less than one-month up to 6 months in majority of cases. Transient voice changes, such as voice fatique, and voice weakness or dysphonia are more common and can happen in most of the cases. The transient voice changes usually occurs because one or more of the nerves are irritated either by moving them out of the way during the dissection of thyroid gland or because of the inflammation or oedema that happens after the thyroid surgery.

One of the indices of success in thyroid surgery is the frequency of complications. The most frequent postoperative complications following thyroidectomy are hypocalcemia and airway complications. These are life threatening and have a significant impact on quality of life . Airway complications may result from postoperative haematoma, vocal cord paralysis, laryngeal oedema, and tracheomalacia .

Recurrent laryngeal nerve palsy (RLNP) is a rare but potentially catastrophic complication of thyroid surgery. Damage to a recurrent laryngeal nerve (RLN) with resultant paralysis of the sole abducting muscle (posterior cricoarytenoid) of the vocal folds can cause symptoms ranging from hoarseness in unilateral lesions to stridor and acute airway obstruction in bilateral damage. RLNP following thyroid surgery is one of the leading reasons for medico-legal litigation against surgeons .

Injury of the laryngeal nerves may not be the only cause of voice changes. Other possible causes include injury of the prethyroid strap muscles and cricothyroid muscles or impairment of laryngotracheal movement due to wound contracture after surgical trauma of the soft tissues. A delicate surgical technique may prevent such complications, but it remains to be clarified whether voice alterations may occur after thyroidectomy without any laryngeal nerve injury. Computerized acoustic analysis of the patients undergoing thyroidectomy without laryngeal nerve injury may help determine possible voice changes objectively .

Dysphagia is a typical symptom experinced preoperatively by patients with enlarged thyroid due to a direct compression of the swallowing organs. In these patients, uncomplicated thyroidectomy often leads to improvements in perceptions of swallowing function. However impaired swallowing and neck strangling frequently occur postoperatively. Intraoperative nerve injury regularly causes postoperative dysphagia, but dysphagia is also complained of after uncomplicated thyroidectomies. These symptoms are usually dismissed by the clinicians or attributed to orotracheal intubation. In many patients, correlations for these swallowing disorders cannot be found in objective test results. Reasons for dysphagia and esophageal motility changes after uncomplicated thyroidectomy could be injury of the perithyroidal neural plexus, changes in the laryngeal vascular supply, postoperative adhesions, decreased pressure of the upper esophageal sphincter, or changed position after thyroidectomy .

Investigate non neurogenic causes of vocal and swallowing changes following thyroid surgery: Vocal cord immobility (VCI) is defined as various spectrum of motion impairment in the vocal cord. Although hoarseness is the main symptom in VCI, dysphonia, odynophonia, dysphagia, chronic cough, and laryngospasm can also occur. Visual inspection by a laryngoscopy and electrophysiologic study, such as laryngeal electromyography (LEMG) can help to differentiate the neurogenic and non-neurogenic causes of VCI. The LEMG technique was first introduced by Weddel et al., and needle electrode insertion in small muscles of larynx with assistance of laryngoscopy or in-surgery was first reported in 1950s, followed by the standardized percutaneous electrode insertion technique. LEMG is not only helpful in diagnosing neuromuscular disorder in the larynx, but it can also be used in botulinum toxin or hyaluronic acid injection in vocal cord. In the process of first diagnosing VCI, various systemic diseases can be suspected from the symptoms. Viral or bacterial infections can attribute to post-infectious neuropathies and a wide spectrum of malignancies or tumors present as a paralysis. Also, VCI can be seen in systematic neurologic diseases such as myasthenia gravis, Charcot-Marie-Tooth disease, and multiple sclerosis. With LEMG results, it aids to select other diagnostic tests and determine timing and type of treatments. Furthermore, LEMG results are useful in predicting negative outcomes and their findings can alter definitive treatments. It is important to diagnose VCI of neurogenic causes and to affect treatment and prognosis. However, there are few research studies regarding the association between the clinical characteristics in VCI and LEMG results .

Conditions
Thyroidectomy
Being tested
Thyroidectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThyroidectomyProcedure or surgery

    Thyroidectomy

Study groups in NCT04087447
Study groupRoleWhat they receive
Thyroidectomy grouppatient undergoing thyroidectomy for simple nodular goiter
Receives: Procedure: Thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of voice function

    fibroptic endoscopic assessment of voice function

    Measured: from end of surgery till two months after surgery

  2. Assessment of swallowing function

    fibroptic endoscopic assessment of swallowing function

    Measured: from end of surgery till two months after surgery

Secondary outcomes (1)
  1. postoperative care of these patients

    this includes improve voice and swallowing dysfunction

    Measured: from end of surgery till two months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start1 Jan 2020 (estimated)
  3. Primary completion1 Jan 2021 (estimated)
  4. Study completion1 Jul 2021 (estimated)

Resources

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
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04087447
Sponsor's protocol ID
Phoniatrics unit 1/2019
Status last verified
Sep 2019
First submitted
11 Sep 2019
Last updated
12 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroidectomy, 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 1 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 12 Sep 2019. 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 Aya Sharkawy, MBBCH (01008137079, Ayasharkawy20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of voice function (time frame: from end of surgery till two months after surgery). 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?
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 12 Sep 2019.

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