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NCT07532889
Comparing Medial and Lateral Dissection Approaches to the Recurrent Laryngeal Nerve During a Thyroidectomy
Conditions: Thyroidectomy
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 430
Sponsor: Oleksandr Butskiy
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.
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
Source: ClinicalTrials.gov (NCT07532889). StuddyBuddy aggregates publicly available trial information.