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NCT Number: NCT07532889

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

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.

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Key information

Conditions

Thyroidectomy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Approach to RLN during Thyroidectomy

Procedure

Medial vs Lateral Approach to RLN during thyroidectomy

Primary outcomes

  1. Intraoperative injury to the RLN

    Time frame: Intraoperatively

    • 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

  2. Temporary vocal cord palsy as defined endoscopically

    Time frame: 2 weeks postoperatively

Secondary outcomes

  1. Hypoparathyroidism

    Time frame: 6 months postoperatively

    • 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

  2. Postoperative hematoma requiring evacuation in the operating room

    Time frame: Immediately following surgery

    Yes/No

  3. Postoperative hematoma not requiring evacuation in the operating room

    Time frame: Immediately following surgery

    Yes/No

  4. Skin to skin operative time (minutes)

    Time frame: Intraoperatively

  5. 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

    Time frame: Intraoperatively

    Reasons for taking a different approach will be documented as well

  6. Permanent vocal cord palsy as defined endoscopically

    Time frame: 6 months postoperatively

  7. Patient scar satisfaction score measured with Patient Scar Assessment Questionnaire (PSAQ)

    Time frame: 2 months postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Oleksandr Butskiy

Other

Collaborators

  • Inomed

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Apr 21, 2026

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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