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
About this trial
This is an interventional treatment trial for Thyroid
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
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
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
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Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Laryngeal Nerve During Thyroidectomy
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