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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04379804
Other study ID # CranioCaudal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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