CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE

Recurrent Laryngeal Nerve Injuries Clinical Trial

Official title:

COMPARISON OF THE INCIDENCE OF RECURRENT LARYNGEAL INJURY FOLLOWING THE DISSECTİON OF THE NERVE BY CRANIO-CAUDAL AND LATERAL APPROACH BY USING INTROPERATIVE NERVE MONITORING

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379804
• Other study ID #: CranioCaudal
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: March 1, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion criteria:

• Multinoduler Goitre

• Thyroid papillary cancer

• Solitary thyroid nodule

Exclusion criteria:

• previous thyroid or parathyroid surgery,

• substernal goiter,

• preoperative VCP,

• evidence of lateral lymph node metastasis,

• intentional transection of the RLN due to tumor invasion,

• failure to assess RLN functioning due to equipment issues with the IONM setup,

• presurgical dissection amplitude of <500µV,

• patient's refusal to participate

Related Conditions & MeSH terms

• Recurrent Laryngeal Nerve Injuries

Intervention

Procedure:
• Lateral approach
Following the ligation of upper pole vessels, the thyroid lobe was pulled anteromedially and the RLN was dissected within the carotid triangle at the level of inferior thyroid artery (ITA).
• Cranio-caudal approach
Following the ligation of upper pole vessels, the upper pole was retracted antero-medially to expose crico-pharyngeal muscle. The RLN was identified at the point of entry both visually and with hand held stimulation probe

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent laryngeal nerve injury	Gross anatomical injury or functional injury demonstrated by nerve monitoring	6 months postoperatively
Secondary	Serum levels of calcium	On the first postoperative day to identify hypocalcemia	First day postoperatively
Secondary	Serum levels of parathormone	On the first postoperative day to identify hypoparathyroidism	First day postoperatively
Secondary	Recovery of 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	20 minutes after initial EMG changes