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.
All patients undergoing a total thyroidectomy or hemithyroidectomy under the care of the participating surgeons
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
Parallel
Approach to RLN during Thyroidectomy
Procedure/SurgeryMedial vs Lateral Approach to RLN during thyroidectomy
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
Temporary vocal cord palsy as defined endoscopically
Hypoparathyroidism
1. 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 2. Permanent hypocalcemia - any hypocalcemia requiring calcium AND vitamin D supplementation for over 6 months post surgery
Postoperative hematoma requiring evacuation in the operating room
Yes/No
Postoperative hematoma not requiring evacuation in the operating room
Yes/No
Skin to skin operative time (minutes)
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This trial is not recruiting at the moment. You can still explore other options:
