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Effect of Reversed Tracking Method for Identification of EBSLN in Thyroid Surgery

Effect of Reversed Tracking Method of Stimulating Cricothyroid Muscles on the Identification and Protection of EBSLN in Thyroid Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03680222
Enrollment
100
Registered
2018-09-21
Start date
2018-10-01
Completion date
2020-09-30
Last updated
2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Laryngeal Nerve Injuries, Thyroid Cancer

Keywords

external branches of superior laryngeal nerve, thyroidectomy, thyroid cancer

Brief summary

The feasibility and effectiveness of Reversed Tracking Method for the identification and protection of extralaryngeal nerve branches in thyroid surgery were analyzed. Evidence-based medical evidence was used to evaluate the importance of EBSLN recognition and protection in thyroid surgery.

Detailed description

The incidence of thyroid cancer in the world is growing rapidly. The current incidence of thyroid cancer in China is about 4.2/100,000, ranking the fourth in the incidence of female malignant tumors. Surgical treatment is the first and most important treatment for thyroid cancer. According to the existing literature, the injury rate of EBSLN in thyroid surgery can be as high as 58%. The quality of sound changes caused by EBSLN injury affects the quality of life of patients after surgery, and even affects the work and career of patients. therefore, seeking better EBSLN protection The method has great social and economic benefits.

Interventions

PROCEDUREReversed Tracking Method

Reversed Tracking Method

Sponsors

Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Different methods of protection of external branches of superior laryngeal nerve

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

: 1. thyroid papillary cancer patients 2. thyroid adenoma patients 3. tumor diameter less than 4cm 4. patients who require only unilateral thyroid surgery as required by the guidelines

Exclusion criteria

1. The upper pole tumor invades the anterior dorsum and may accumulate the area of the superior laryngeal nerve; 2. Patients who have previously performed head and neck surgery; 3. Preoperative laryngoscopy and sound assessment abnormalities or previous vocal cord surgery history; 4. If there is a language or hearing impairment, the follow-up assessment cannot be completed; 5. The assessment failure of nerve function due to the technical deficiency of the IONM equipment Elimination criteria: 1. Patients with recurrent laryngeal nerve palsy after surgery affect the evaluation of the laryngeal nerve. 2. The patient is asked to withdraw from the follow-up assessment midway.

Design outcomes

Primary

MeasureTime frameDescription
The identification rate of the external branch of the superior laryngeal nerve.up to 6 months postoperativelyThe identification rate of the external branch of the superior laryngeal nerve.

Secondary

MeasureTime frameDescription
videostrobolaryngoscopyup to 6 months postoperativelyThe voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.
analysis of maximum phonation time (MPT)up to 6 months postoperativelyThe voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.
Friedman classificationup to 6 months postoperativelyAnatomical variability of the external branch of the superior laryngeal nerve according to Friedman classification.
fundamental frequency (Fo)up to 6 months postoperativelyThe voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.
voice quality rating on GRBAS scaleup to 6 months postoperativelyThe voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.
voice level (VL)up to 6 months postoperativelyThe voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.

Countries

China

Contacts

Primary ContactBo Wang, md
wangbo@fjmu.edu.cn13705947900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026