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

NCT03680222 | Unknown DMC

• 1 other identifier: IONM diffusion for EBSLN
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer; Recurrent Laryngeal Nerve Injuries

Keywords

external branches of superior laryngeal nerve; thyroidectomy; thyroid cancer

Outcome Measures

Primary Outcomes (1)

• The identification rate of the external branch of the superior laryngeal nerve.

  The identification rate of the external branch of the superior laryngeal nerve.

  up to 6 months postoperatively

Secondary Outcomes (6)

• Friedman classification

  up to 6 months postoperatively

• videostrobolaryngoscopy

  up to 6 months postoperatively

• analysis of maximum phonation time (MPT)

  up to 6 months postoperatively

• voice level (VL)

  up to 6 months postoperatively

• fundamental frequency (Fo)

  up to 6 months postoperatively

Study Arms (2)

Standard method

NO INTERVENTION

Standard method recommended by the guide

Reversed Tracking Method

EXPERIMENTAL

Reversed Tracking Method

Procedure: Reversed Tracking Method

Interventions

Reversed Tracking Method PROCEDURE

Reversed Tracking Method

Reversed Tracking Method

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• thyroid papillary cancer patients
• thyroid adenoma patients
• tumor diameter less than 4cm
• patients who require only unilateral thyroid surgery as required by the guidelines

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• wenxin zhao, md

  Fujian Medical University Union Hospital

  STUDY CHAIR

Central Study Contacts

Bo Wang, md

CONTACT

13705947900; wangbo@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: Different methods of protection of external branches of superior laryngeal nerve

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 21, 2018
• Study Start: October 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2020
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)