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

N/ANot Yet RecruitingNCT07532889

Oleksandr Butskiy430 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

430

Conditions

Thyroidectomy

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Intraoperatively

Temporary vocal cord palsy as defined endoscopically

Time frame: 2 weeks postoperatively

Secondary Outcomes

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

Time frame: 6 months postoperatively

Postoperative hematoma requiring evacuation in the operating room

Yes/No

Time frame: Immediately following surgery

Postoperative hematoma not requiring evacuation in the operating room

Yes/No

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

Reasons for taking a different approach will be documented as well

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