NCT05421559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

June 13, 2022

Last Update Submit

June 13, 2022

Conditions

ThyroidSurgeryThyroid Disease

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (2)

conventional approach of thyroidectomy

ACTIVE COMPARATOR

conventional method of thyroidectomy with ST muscle retraction

Procedure: thyroidectomy

transection approach of thyroidectomy

ACTIVE COMPARATOR

method of thyroidectomy with ST muscle transection

Procedure: thyroidectomy

Interventions

thyroidectomyPROCEDURE

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

conventional approach of thyroidectomytransection approach of thyroidectomy

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr, assistant lecturer of General Surgery

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 16, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)