Thyroid Surgery Clinical Trial
Official title:
Intra-operative Monitoring of the External Branch of the Superior Laryngeal Nerve (EBSLN) During Thyroid Surgery: Does it Improve Voice Preservation?
Verified date | June 2019 |
Source | The Royal Wolverhampton Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Thyroid surgeons place an enormous amount of importance and rightly so to the preservation of
the recurrent laryngeal nerve (RLN) during thyroidectomies. A good knowledge of the anatomy
of the nerve and meticulous dissection technique and intraoperative identification of the
nerve are crucial to the anatomic and functional integrity of the nerve. The use of
intraoperative neural monitoring to aid the surgeon in the identification of the RLN has
gained acceptance and is considered standard practice in several units. However, lesser
emphasis has been placed historically on the identification and preservation of the external
branch of the superior laryngeal nerve (EBSLN) during thyroid surgery. The EBSLN supplies the
cricothyroid muscle that controls pitch variation during phonation. Unlike damage to the
recurrent laryngeal nerve which manifests readily as vocal cord paralysis, intraoperative
damage to EBSLN is difficult to assess postoperatively as visual assessment of the larynx is
not indicative of the integrity of the nerve. Injury of the EBSLN can cause weakness or
complete paralysis of the ipsilateral cricothyroid muscle. Patients may report a deeper voice
or an inability to produce high pitched sounds.
Patients may also complain of weakness, tightness of the voice, and require extra effort to
speak. Of note, voice changes with EBSLN injury are subtle in the general population but can
be devastating in patients who depend on their voice for a living. Importantly, EBSLN injury
is reported in upto 50% of thyroid surgery in contrast to 12% of recurrent laryngeal nerve
injury during thyroid surgery. The new guidelines published in the Laryngoscope recommend
routine intraoperative neural monitoring of EBSLN. The Investigators have a functional system
in use currently for monitoring recurrent laryngeal nerve intraoperatively and propose to
study the impact of monitoring the EBSLN using the same neural monitoring device to improve
voice results following thyroid surgery.
Status | Completed |
Enrollment | 9 |
Est. completion date | October 1, 2018 |
Est. primary completion date | October 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients undergoing diagnostic hemithyroidectomies (thyroid nodules 5 cm or less). - age 18 and over - able to provide informed consent Exclusion Criteria: - Patients who develop a recurrent laryngeal nerve palsy following surgery will be excluded from the study. - Patients who withdraw consent during or after study - Patients with pre-existing laryngeal pathology like reinkes edema, vocal cord nodules, laryngeal inflammation, previous laryngeal surgery etc - Pregnant women (confirmed by history and routine pregnancy test) - Those unable to give informed consent - Previous major neck surgery such as neck dissections, laryngeal surgery, carotid endarterectomies, parathyroid and thyroid surgery. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Wolverhampton NHS Trust | Wolverhampton | West Midlands |
Lead Sponsor | Collaborator |
---|---|
The Royal Wolverhampton Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intact external branch of the superior laryngeal nerve | Review and feedback via questionnaire of superior laryngeal nerve | 6 months |
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