Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Laryngeal Nerve During Thyroidectomy

Surgery Clinical Trial

Official title:

Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421559
• Other study ID #: MKSU50-6-9
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: June 2022
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The sternothyroid (ST) muscle is closely adherent to the thyroid gland with oblique insertion into the thyroid cartilage. EBSLN passes through the sternothyroid laryngeal triangle with a parallel course deep to the ST muscle. This study evaluates the transection of the sternothyroid muscle as a key step during thyroidectomy to increase the rate of exposure and visual identification of EBSLN compared to ST muscle retraction as a traditional technique.

Description:

The study was conducted on patients eligible for total thyroidectomy, which meets the standard of the ATA Thyroid Guidelines. Preoperative biochemical thyroid function tests and neck ultrasound with FNAC of suspicious nodules confirmed the clinical diagnosis. Patients who had previously undergone neck surgery or irradiation or were preoperatively diagnosed with a vocal cord movement disorder, a vocal cord benign lesion, or speech disorders were excluded from the study. A random number was used to determine the patient group allocation. Data about patients were gathered via history, examinations, and investigations. The patients were randomized (computer-generated) with the use of an opaque-sealed envelope into two groups; group A: conventional method of thyroidectomy with ST muscle retraction, group B: transection of ST muscle. The study's primary endpoint was the identification rate of the EBSLN in both techniques. The secondary endpoints included: a comparison of operative time in both techniques as well as anatomical variability of the EBSLN according to Cernea classification, rate of injury of EBSLN, and changes in postoperative voice performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• eligible for total thyroidectomy
• no previous history of neck surgery or radiation
• no vocal cord pathology
• no voice disorders

Exclusion Criteria:

• not fit for surgery
• previous history of neck surgery or radiation
• vocal cord pathology
• vocal cord movement disorders

Related Conditions & MeSH terms

• Surgery
• Thyroid
• Thyroid Disease
• Thyroid Diseases

Intervention

Procedure:
• thyroidectomy
removal of the diseased thyroid gland by conventional method vs transection method of sternothryroid muscle

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafr Al Sheikh

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Aouf

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of identification and exposure of the external laryngeal nerve during thyroidectomy		1 year