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| Name | Class |
|---|---|
| Inomed | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medial Approach | Experimental | Following the division of the isthmus, the edge on the resection side is grasped with Babcock forceps, placing it on lateral traction. The thyroid gland is then separated from the cricothyroid muscle and the trachea medially, leaving the berry's suspensory ligament adjacent to the first tracheal ring intact. The avascular space between the superior pole and the cricothyroid muscle is open. Finally, in the most critical step, the berry's ligament lateral to the first tracheal ring is placed on differential traction using two retractors - facilitating careful identification of the RLN as it courses under the superior edge of the berry's ligament - entering the larynx beneath the cricopharyngeus muscle. The RLN is identified at its most distal and consistent location as it enters the larynx. |
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| Lateral Approach | Active Comparator | In the lateral approach group, the superior thyroid pedicle is mobilized and ligated, followed by medial rotation of the thyroid gland with division of the middle thyroid vein. Then, the RLN is identified in between the tubercle of Zuckerkandl and the cricothyroid joint. Berry's suspensory ligament is then divided. The thyroid lobe will then be completely dissected from the trachea as the final step in lobectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Approach to RLN during Thyroidectomy | Procedure | Medial vs Lateral Approach to RLN during thyroidectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative injury to the RLN |
| Intraoperatively |
| Temporary vocal cord palsy as defined endoscopically | 2 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoparathyroidism |
| 6 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Postoperative hematoma requiring evacuation in the operating room | Yes/No | Immediately following surgery |
| Postoperative hematoma not requiring evacuation in the operating room | Yes/No | Immediately following surgery |
| Skin to skin operative time (minutes) | 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 | Reasons for taking a different approach will be documented as well | Intraoperatively |
| Permanent vocal cord palsy as defined endoscopically | 6 months postoperatively |
| Patient scar satisfaction score measured with Patient Scar Assessment Questionnaire (PSAQ) | 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. | 2 months postoperatively |