Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00661024
First received: April 15, 2008
Last updated: April 17, 2008
Last verified: April 2008

April 15, 2008
April 17, 2008
January 2006
June 2007   (final data collection date for primary outcome measure)
the incidence of the recurrent laryngeal nerve injury [ Time Frame: on 2nd postoperative day and than at 1, 2, 4, 6 and 12 months postoperatively, if paresis was noted on first examination ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00661024 on ClinicalTrials.gov Archive Site
  • the IONM-added value to RLN identification [ Time Frame: intraopreratively ] [ Designated as safety issue: Yes ]
  • the value of IONM in prediction of postoperative vocal cords function [ Time Frame: intraoperative data compared with observation of vocal cords function postoperatively on the 2nd day postop ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Thyroid Surgery
  • Procedure: intraoperative RLN visualization
    intraoperative RLN visualization
    Other Name: V-G
  • Procedure: intraoperative neuromonitoring of the RLN
    IONM
    Other Name: IONM-G
  • Placebo Comparator: 1
    RLN visualization alone
    Intervention: Procedure: intraoperative RLN visualization
  • Experimental: 2
    IONM of the RLN
    Intervention: Procedure: intraoperative neuromonitoring of the RLN

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
April 2008
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • thyroid pathology qualified for first-time bilateral neck surgery

Exclusion Criteria:

  • previous thyroid or parathyroid surgery,
  • unilateral thyroid pathology eligible for minimally invasive approach (MIVAT),
  • mediastinal goiter,
  • preoperatively diagnosed RLN palsy,
  • pregnancy or lactation,
  • age below 18 years,
  • high-risk patients ASA 4 grade (American Society of Anesthesiology),
  • and inability to comply with the scheduled follow-up protocol.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00661024
BBN/501/ZKL/L
Yes
Marcin Barczynski, MD, PhD, Jagiellonian University
Jagiellonian University
Not Provided
Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University
Study Chair: Stanislaw Cichon, Prof, MD Jagiellonian University
Study Director: Aleksander Konturek, MD, PhD Jagiellonian University
Jagiellonian University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP