Thyroidectomy
Conditions
Keywords
Thyroidectomy, Medial Approach to Thyroidectomy, Lateral Approach to Thyroidectomy, Continuous Nerve Monitoring
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.
Interventions
PROCEDUREApproach to RLN during Thyroidectomy
Medial vs Lateral Approach to RLN during thyroidectomy
Sponsors
Oleksandr Butskiy
Inomed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative injury to the RLN | Intraoperatively | 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 | 2 weeks postoperatively | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient scar satisfaction score measured with Patient Scar Assessment Questionnaire (PSAQ) | 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. |
| Individual Adverse Events to the RLN | Intraoperatively | An event wherein 50% reduction in EMG amplitude OR 10% latency is observed on CIONM. |
| Hypoparathyroidism | 6 months postoperatively | 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 | Immediately following surgery | Yes/No |
| Postoperative hematoma not requiring evacuation in the operating room | Immediately following surgery | Yes/No |
| 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 | Reasons for taking a different approach will be documented as well |
| Skin to skin operative time (minutes) | Intraoperatively | — |
| Permanent vocal cord palsy as defined endoscopically | 6 months postoperatively | — |
Outcome results
None listed