Comparing Medial and Lateral Dissection Approaches to the Recurrent Laryngeal Nerve During a Thyroidectomy

The Use of Continuous Nerve Monitoring to Compare Rates of Recurrent Laryngeal Nerve Injury Between Medial and Lateral Dissection Approaches to the Recurrent Laryngeal Nerve During a Thyroidectomy: A Prospective Randomized Controlled Trial

The goal of this interventional study is to compare the effectiveness of two surgical approaches in identifying the recurrent laryngeal nerve (RLN) during thyroidectomy. The main questions it aims to answer are:

How does each approach affect the length of hospital stay? How does each approach affect the number of adverse events that occur during surgery? How does each approach affect vocal cord function after surgery?

Researchers will compare the new medial approach to the standard lateral approach to evaluate its effectiveness.

Participants scheduled to undergo thyroidectomy surgery will be randomly assigned to one of these approaches after informed consent is obtained. Data will be collected during and after the surgery by a research assistant.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroidectomy
• Intervention / Treatment: Procedure: Approach to RLN during Thyroidectomy

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients undergoing a total thyroidectomy or hemithyroidectomy under the care of the participating surgeons

Exclusion Criteria:

• Age less than 19 years old
• Previous thyroid or parathyroid surgery, substernal goiter, preoperative vocal cord palsy (VCP)
• Evidence of lateral or central neck lymph node metastases
• Intentional iatrogenic transection of the RLN due to tumor invasion
• Failure to assess real-time RLN functioning due to equipment issues with the IONM setup
• Presurgical dissection amplitude under 100uV
• Patient refusal to participate in the study
• Intraoperative decision to switch to a different approach to identifying the RLN

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medial Approach; Following the division of the isthmus, the edge on the resection side is grasped with Babcock forceps, placing it on lateral traction. The thyroid gland is then separated from the cricothyroid muscle and the trachea medially, leaving the berry's suspensory ligament adjacent to the first tracheal ring intact. The avascular space between the superior pole and the cricothyroid muscle is open. Finally, in the most critical step, the berry's ligament lateral to the first tracheal ring is placed on differential traction using two retractors - facilitating careful identification of the RLN as it courses under the superior edge of the berry's ligament - entering the larynx beneath the cricopharyngeus muscle. The RLN is identified at its most distal and consistent location as it enters the larynx.	Procedure: Approach to RLN during Thyroidectomy; Medial vs Lateral Approach to RLN during thyroidectomy
Active Comparator: Lateral Approach; In the lateral approach group, the superior thyroid pedicle is mobilized and ligated, followed by medial rotation of the thyroid gland with division of the middle thyroid vein. Then, the RLN is identified in between the tubercle of Zuckerkandl and the cricothyroid joint. Berry's suspensory ligament is then divided. The thyroid lobe will then be completely dissected from the trachea as the final step in lobectomy.	Procedure: Approach to RLN during Thyroidectomy; Medial vs Lateral Approach to RLN during thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative injury to the RLN	LOS - as defined by a decline of amplitude to <100uV as measured by CIONM; Combined adverse events - an event wherein both 50% reduction in EMG amplitude and 10% latency are observed on CIONM	Intraoperatively
Temporary vocal cord palsy as defined endoscopically		2 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoparathyroidism	Temporary hypocalcemia - ionized calcium <1.0 mmol/L on post operative day 1 OR any requirement for calcium AND vitamin D supplementation for 6 months or less post surgery; Permanent hypocalcemia - any hypocalcemia requiring calcium AND vitamin D supplementation for over 6 months post surgery	6 months postoperatively
Postoperative hematoma requiring evacuation in the operating room	Yes/No	Immediately following surgery
Postoperative hematoma not requiring evacuation in the operating room	Yes/No	Immediately following surgery
Skin to skin operative time (minutes)		Intraoperatively
Number of instances that the patient was randomized to a specific approach to identifying the RLN, but a different approach was taken by the surgeon	Reasons for taking a different approach will be documented as well	Intraoperatively
Permanent vocal cord palsy as defined endoscopically		6 months postoperatively
Patient scar satisfaction score measured with Patient Scar Assessment Questionnaire (PSAQ)	Each of the following 5 subscales are assessed by assigning number values to patients' responses, with 1 being most favourable and 4 being most unfavourable: Appearance, Symptoms, Consciousness, Satisfaction with Appearance and Satisfaction with Symptoms.	2 months postoperatively

Collaborators and Investigators

• Sponsor: Oleksandr Butskiy
• Collaborators: Inomed

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Thyroidectomy; Medial Approach to Thyroidectomy; Lateral Approach to Thyroidectomy; Continuous Nerve Monitoring
• Other Study ID Numbers: H24-02160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No