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

NCT ID: NCT05421559

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-02-01

Brief 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.

Detailed 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.

Conditions

Thyroid; Surgery; Thyroid Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

conventional approach of thyroidectomy

conventional method of thyroidectomy with ST muscle retraction

Group Type: ACTIVE_COMPARATOR

thyroidectomy

Intervention Type: PROCEDURE

removal of the diseased thyroid gland by conventional method vs transection method of sternothryroid muscle

transection approach of thyroidectomy

method of thyroidectomy with ST muscle transection

Group Type: ACTIVE_COMPARATOR

thyroidectomy

Intervention Type: PROCEDURE

removal of the diseased thyroid gland by conventional method vs transection method of sternothryroid muscle

Interventions

thyroidectomy

removal of the diseased thyroid gland by conventional method vs transection method of sternothryroid muscle

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Aouf

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Aouf

Dr, assistant lecturer of General Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Countries

Egypt

Other Identifiers

MKSU50-6-9

Identifier Type: -

Identifier Source: org_study_id