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Not yet recruiting NCT07532889

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

No phase Interventional Thyroidectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Approach to RLN during Thyroidectomy.
Who it may be relevant to
Registry conditions: Thyroidectomy. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Procedure Approach to RLN during Thyroidectomy
    Medial vs Lateral Approach to RLN during thyroidectomy

Primary outcome measures

  • Intraoperative injury to the RLN [Time frame: Intraoperatively]
  • Temporary vocal cord palsy as defined endoscopically [Time frame: 2 weeks postoperatively]
Secondary outcome measures (7)
  • Hypoparathyroidism [Time frame: 6 months postoperatively]
  • Postoperative hematoma requiring evacuation in the operating room [Time frame: Immediately following surgery]
  • Postoperative hematoma not requiring evacuation in the operating room [Time frame: Immediately following surgery]
  • Skin to skin operative time (minutes) [Time frame: 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 [Time frame: Intraoperatively]
  • Permanent vocal cord palsy as defined endoscopically [Time frame: 6 months postoperatively]
  • Patient scar satisfaction score measured with Patient Scar Assessment Questionnaire (PSAQ) [Time frame: 2 months postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07532889 · H24-02160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗