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

Primary Purpose

Thyroid, Surgery, Thyroid Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
thyroidectomy
Sponsored by
Ahmed Aouf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kafrelsheikh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

conventional approach of thyroidectomy

transection approach of thyroidectomy

Arm Description

conventional method of thyroidectomy with ST muscle retraction

method of thyroidectomy with ST muscle transection

Outcomes

Primary Outcome Measures

rate of identification and exposure of the external laryngeal nerve during thyroidectomy

Secondary Outcome Measures

Full Information

First Posted
June 13, 2022
Last Updated
June 13, 2022
Sponsor
Ahmed Aouf
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1. Study Identification

Unique Protocol Identification Number
NCT05421559
Brief Title
Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Laryngeal Nerve During Thyroidectomy
Official Title
Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Aouf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid, Surgery, Thyroid Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional approach of thyroidectomy
Arm Type
Active Comparator
Arm Description
conventional method of thyroidectomy with ST muscle retraction
Arm Title
transection approach of thyroidectomy
Arm Type
Active Comparator
Arm Description
method of thyroidectomy with ST muscle transection
Intervention Type
Procedure
Intervention Name(s)
thyroidectomy
Intervention Description
removal of the diseased thyroid gland by conventional method vs transection method of sternothryroid muscle
Primary Outcome Measure Information:
Title
rate of identification and exposure of the external laryngeal nerve during thyroidectomy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kafrelsheikh University
City
Kafr Ash Shaykh
State/Province
Kafr Al Sheikh
ZIP/Postal Code
33516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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