Clinical trial NCT04379804: CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Laryngeal Nerve Injuries
Keywords: cranio-caudal approach
lateral approach
intraoperative nerve monitoring
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Sisli Hamidiye Etfal Training and Research Hospital
First posted: 2020-05-08
Enrollment: 198
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent laryngeal nerve injury
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Serum levels of calcium
timeFrame: First day postoperatively
measure: Serum levels of parathormone
timeFrame: First day postoperatively
measure: Recovery of EMG changes
timeFrame: 20 minutes after initial EMG changes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Yalin İscan
role: PRINCIPAL_INVESTIGATOR
References: