CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE

Not Applicable

Completed

• Conditions: Recurrent Laryngeal Nerve Injuries

• Registration Number: NCT04379804
• Lead Sponsor: Istanbul University

Brief Summary

The recurrent laryngeal nerve (RLN) dissection should be performed cranio-caudally in TOETVA approach.The aim of this study was to compare the cranio-caudal and lateral approach for RLN dissection in regard with the rates of LOS during conventional thyroidectomy using continuous intraoperative nerve monitoring (CIONM).

Detailed Description

During the thyroid surgery, the identification of the recurrent laryngeal nerve (RLN) and the dissection through its entry point is still the gold standard in prevention of the nerve injury and to decrease the RLN palsy rate. Intraoperative nerve monitoring (IONM) has also so many benefits to search, identify and dissect the nerve through its course during thyroid surgery and especially the most important benefit of the IONM is to have real time information about the function of the RLN. Most of the endocrine surgeons use the inferolateral approach for RLN identification under the guidance of the IONM in the recent years. However after the definition of the transoral endoscopic thyroidectomy vestibular approach (TOETVA) technique, the approach to the RLN have to be changed to craniocaudal approach in which a way that most of the surgeons are not familiar with. The different approaches of the recurrent laryngeal nerve depend on the indications and on the surgeon's habit. Several approaches exist such as the superior approach ,the lateral approach, and the inferior approach.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-11-30
• Study Completion: 2020-03-01
• Study First Submitted: 2020-04-18
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-07
• Study First Posted: 2020-05-08
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrent laryngeal nerve injury	6 months postoperatively	Gross anatomical injury or functional injury demonstrated by nerve monitoring

Secondary Outcome Measures

Name	Time	Method
Serum levels of calcium	First day postoperatively	On the first postoperative day to identify hypocalcemia
Serum levels of parathormone	First day postoperatively	On the first postoperative day to identify hypoparathyroidism
Recovery of EMG changes	20 minutes after initial EMG changes	adverse EMG parameters were defined as amplitude decrease of 50% or more of baseline value and,or latency increase of 10% or more

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey