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Completed

NCT Number: NCT04379804

CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE

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).

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, 34752, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lateral approach

Procedure

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

Procedure

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

Primary outcomes

  1. Recurrent laryngeal nerve injury

    Time frame: 6 months postoperatively

    Gross anatomical injury or functional injury demonstrated by nerve monitoring

Secondary outcomes

  1. Serum levels of calcium

    Time frame: First day postoperatively

    On the first postoperative day to identify hypocalcemia

  2. Serum levels of parathormone

    Time frame: First day postoperatively

    On the first postoperative day to identify hypoparathyroidism

  3. Recovery of EMG changes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Sisli Hamidiye Etfal Training and Research Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 8, 2020
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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