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CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04379804
Enrollment
198
Registered
2020-05-08
Start date
2018-06-01
Completion date
2020-03-01
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Laryngeal Nerve Injuries

Keywords

cranio-caudal approach, lateral approach, intraoperative nerve monitoring

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.

Interventions

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).

PROCEDURECranio-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

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
CollaboratorOTHER
Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Computer generated random numbers were generated and printed on cards. These cards were placed in sealed, opaque envelopes. On the morning of operation, one envelope was opened before the operation and, depending of the parity of the number, RLN's of the patient were dissected either by cranio-caudal or lateral dissection during the operation.

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrent laryngeal nerve injury6 months postoperativelyGross anatomical injury or functional injury demonstrated by nerve monitoring

Secondary

MeasureTime frameDescription
Serum levels of calciumFirst day postoperativelyOn the first postoperative day to identify hypocalcemia
Serum levels of parathormoneFirst day postoperativelyOn the first postoperative day to identify hypoparathyroidism
Recovery of EMG changes20 minutes after initial EMG changesadverse EMG parameters were defined as amplitude decrease of 50% or more of baseline value and,or latency increase of 10% or more

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026