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

NCT ID: NCT03680222

Last Updated: 2018-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-09-30

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.

Conditions

Thyroid Cancer; Recurrent Laryngeal Nerve Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard method

Standard method recommended by the guide

Group Type: NO_INTERVENTION

No interventions assigned to this group

Reversed Tracking Method

Reversed Tracking Method

Group Type: EXPERIMENTAL

Reversed Tracking Method

Intervention Type: PROCEDURE

Reversed Tracking Method

Interventions

Reversed Tracking Method

Reversed Tracking Method

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bo Wang,MD

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

wenxin zhao, md

Role: STUDY_CHAIR

Fujian Medical University Union Hospital

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bo Wang, md

Role: CONTACT

wangbo@fjmu.edu.cn

13705947900

Facility Contacts

bo wang, md

Role: primary

wangbo@fjmu.edu.cn

13705947900

Other Identifiers

IONM diffusion for EBSLN

Identifier Type: -

Identifier Source: org_study_id