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

NCT07532889 | Not Yet Recruiting

• 1 other identifier: H24-02160
• Study Type: interventional
• Target: 430
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thyroidectomy

Keywords

Thyroidectomy; Medial Approach to Thyroidectomy; Lateral Approach to Thyroidectomy; Continuous Nerve Monitoring

Outcome Measures

Primary Outcomes (2)

• Intraoperative injury to the RLN

  1. LOS - as defined by a decline of amplitude to \<100uV as measured by CIONM 2. 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 Outcomes (7)

• Hypoparathyroidism

  6 months postoperatively

• Postoperative hematoma requiring evacuation in the operating room

  Immediately following surgery

• Postoperative hematoma not requiring evacuation in the operating room

  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

  Intraoperatively

Study Arms (2)

Medial Approach

EXPERIMENTAL

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

Lateral Approach

ACTIVE COMPARATOR

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

Interventions

Approach to RLN during Thyroidectomy PROCEDURE

Medial vs Lateral Approach to RLN during thyroidectomy

Lateral Approach; Medial Approach

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oleksandr Butskiy: lead
• Inomed: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The patients will be randomized to have RLNs identified by lateral or medial approach. There are 3 relevant modalities of thyroidectomy within this study: total thyroidectomy, hemithyroidectomy and completion thyroidectomy. In total thyroidectomy, one side will receive the medial approach and one side with lateral approach, but the order and which lobe receives which will be randomized. For hemithyroidectomy and completion thyroidectomy, where one lobe is removed, randomization will dictate whether the lateral or medial approach to identifying the RLN will be used.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04