Thyroid Surgery Clinical Trial
Official title:
Randomized Clinical Trial Evaluating Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery
Some recent studies have shown that intraoperative neuromonitoring (IONM) can aid the recurrent laryngeal nerve (RLN) identification during thyroid surgery. However, the role of IONM in reducing the incidence of RLN injury rate and the value of this method in predicting postoperative RLN function remain controversial. Only a few published series represent level III of evidence and grade C of recommendation according to the evidence-based criteria (Sackett's classification, modified by Heinrich). Thus, the aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thyroid surgery.
Apart from hypoparathyroidism, dysfunction of the recurrent laryngeal nerve (RLN) is the
most common complication following thyroid surgery. In consequence, the voice impairment
leading to communication work-related problems and affecting psychological and social
aspects of the individual's functioning diminishes the overall quality of life, being the
common reason for medicolegal claims and litigation. The reported RLN palsy rate varies in
the literature from 0% (for first-time thyroid surgery performed by an experienced endocrine
surgeon) to as much as 20% (for reoperative thyroid surgery or thyroid malignancy surgery
performed in low-volume centers), depending mostly on the type of thyroid disease (benign
vs. malignant goiter), type (first-time vs. reoperation) and the extent of thyroid resection
(subtotal vs. total thyroidectomy), surgical technique (with or without routine RLN
identification) and the surgeon's experience (low-volume vs. high-volume thyroid surgery
center.
In 1938, Lahey from Boston reported a significantly lower incidence of RLN injuries
following thyroidectomy with dissection and visualization of the nerves as compared to
operations without nerve identification. Since that time, many prospective studies have
confirmed this observation, advocating routine RLN identification as the gold standard in
safe thyroid surgery. But even in the most experienced hands RLN palsy occurs occasionally,
with an average frequency below 1% of nerves at risk due to variability in RLNs anatomy and
difficulties in nerve identification by visual or palpation control in challenging
conditions (e.g. advanced thyroid malignancy or reoperative thyroid surgery). On the other
hand, the use of intraoperative electrical stimulation for identifying the RLN nerve was
described in 1966. However, the technique of intraoperative neuromonitoring (IONM) of RLN
did not gain any widespread popularity until the late nineties of the last century, when
several commercial user-friendly systems based on electromyographic signal recording became
available. In these IONM systems, the RLN nerve stimulation is registered by elicited
laryngeal muscles activity through the endoscopic insertion of the electrodes into the vocal
cords, open insertion of the needle electrodes into the vocal muscles through the
cricothyroid ligament or with the use of endotracheal tube surface electrodes. In addition
to a plethora of signal acquisition techniques used in IONM, there is no consensus regarding
the optimal method for nerve activity recording (continuous recording of spontaneous nerve
activity versus repetitive stimulation) and no agreement as to which quantitative
electromyographic parameter should be used as a predictor of postoperative vocal cord
dysfunction (supramaximal versus minimal stimulation of the nerve at the end of the
operation).
Some recent studies have shown that IONM can aid the RLN identification. However, the role
of IONM in reducing the incidence of RLN injury rate and the value of this method in
predicting postoperative RLN function remain controversial. Only a few published series
represent level III of evidence and grade C of recommendation according to the
evidence-based criteria (Sackett's classification, modified by Heinrich). Large,
prospective, randomized trials addressing these issues and allowing for grade A
recommendations are lacking due to some ethical concerns and large numbers of patients in
each arm (more than 7000 patients) needed to reach the appropriate power of the study. To
fulfill this gap in evidence, we designed a medium-size, single-center, prospective
randomized study suitable for drawing more meaningful conclusions. Thus, the aim of this
study was to compare the impact of RLN visualization versus IONM on their morbidity
following thyroid surgery.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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