Symptoms and General Pathology

All Conditions

Neoplasms

Gland and Hormone Related Diseases

Nervous System Diseases

Recurrence

Thyroid Neoplasms

Thyroid Diseases

Paralysis

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Intra operative nerve monitoring (IONM) is a technique of monitoring the RLN during surgery, to help identification and safe guarding of the nerve during total thyroidectomy as well as central compartment clearance (CCC). This is a well established technique with many centers in the world routinely using monitoring during surgery.

Patients randomized to this arm will undergo total thyroidectomy as per standard procedures with visual identification of the RLNs

The standardized technique of IONM-RLNs (bilaterally) will be used, including indirect vagal response evaluation at the beginning and also at the end of surgery according to the recommendations formulated by the International Intraoperative Neural Monitoring Study Group (INMSG) (Randolph GW, Dralle H. 2011).

IONM tube

Gouri Pantvaidya, MS,DNB,MRCS

Scientific objectives:

Primary objective:

• To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery

Secondary objectives:

* To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers
* To assess voice parameters in patients with RLN palsy

Methodology:

All patients undergoing total thyroidectomy with or without central compartment neck dissection, for thyroid cancers, will be eligible for participation. After confirmation of eligibility and obtaining informed consent, all patients will undergo preoperative screening procedures. Fibreoptic laryngoscopy (FOL) examination will be done to document function of the vocal cords. Preoperative voiceevaluation, GRBAS voice scale assessment and Voice Related Quality of Life (VR-QOL) assessment will be performed for all patients. Patients will then be randomized in a 1:1 ratio to receive IONM or not during surgery. Patients will be stratified as per predefined stratification factors. After surgery, endpoint assessment of vocal cord mobility will be done with a FOL study, by an assessor blinded to the randomization arm. Voice evaluation, GRBAS scale assessment and VR QOL assessment will also be done. An event will be defined as any vocal fold paresis/palsy. Patients without the event will be followed up for 6 months while patients with the event will be followed up for 2 years to assess recovery of vocal cord function and changes in speech parameters. All patients with vocal cord paresis/palsy will be given speech and swallowing rehabilitation

Background and rationale of the study:

The incidence of the thyroid carcinoma has dramatically increased in the last few decades.1Total thyroidectomy with or without central compartment dissection is the treatment of choice for thyroid carcinoma. Vocal cord palsy (VCP) due to injury to the recurrent laryngeal nerve (RLN) is one of the most dreaded complications of this surgery. The symptoms associated with this complication include hoarseness of voice, voice fatigue and aspiration. Vocal cord palsy can be either temporary or permanent. The reported incidence of temporary VCP varies from 0-12%.2-4 However, the incidence of permanent VCP has been reported to be much lower varying from 0 to 3.5%.4,5Many patients may not present with symptoms of hoarseness and a post-operative laryngoscopic examination is required in all patients who have undergone surgery for thyroid cancer.6 However, the morbidity associated with VCP significantly affects the quality of life of the patient and at times require intervention to prevent aspiration or to improve voice quality.7 In a recent publication from our institute the invesigator found a temporary VCP rate of 11.8%.8

Intra operative nerve monitoring (IONM) is a technique of monitoring the RLN during surgery, to help identification and safe guarding of the nerve during total thyroidectomy as well as central compartment clearance (CCC). This is a well established technique with many centers in the world routinely using monitoring during surgery. There have been 4 RCTs and 2 meta analysis looking at the role of IONM in decreasing RLN palsy after thyroidectomy. The results from the same have been equivocal with 3 of 4 RCTs showing no added benefit in decreasing RLN palsy rates with the use of IONM.9-12 Of the 2 meta analysis, there was a decrease in RLN palsy rates in one of the meta analysis. 13 however the other Meta analysis by Higgins et al showed no improvement in RLN palsy rates with the use of IONM.14 In the meta analysis by Yang et al, published in 2016, there was a 44% (p=ns) decrease in temporary RLN palsy rates in the thyroid cancer cohort. However, the literature on use of IONM is still equivocal in literature. The other issue with available literature on use of IONM is that, most studies have looked at a heterogenous population of patients being operated for benign and malignant disease. Also most patients in the series evaluated have been patients who have undergone surgery for benign multinodular goiters. The extent of RLN dissection in these patients is limited as compared to patients undergoing surgery for thyroid cancers which involve total thyroidectomy and central compartment dissections. There have been no RCTs looking at the role of IONM in preventing RLN palsy in thyroid cancer surgeries. Also none of the RCTs performed have had a formal sample size calculation and robust analysis.

Section B: Aims and Objectives Aim: To assess the role of IONM in thyroid cancer surgery

Primary objective:

• To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery

Secondary objectives:

* To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers
* To assess voice parameters in patients with RLN palsy

Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.

Phase III, Assessor Blinded, Randomised Controlled Trial of Use of Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery(ACTION)

The vocal cord mobility of each patient will be documented as mobile, fixed or restricted. Restriction of VC movement will be considered as an event for analysis. Other parameters like phonatory gap, arytenoid position, aspiration evaluation will also be done and recorded.

GRBAS score (Grade of Roughness, Breathiness, Asthenia and Strain)

Tata Memorial Hospital

Professor and Consultant Surgeon Department of Head & Neck Surgery, Tata Memorial Centre Secretary, Data Safety Monitoring Unit

Thyroid Cancer, Papillary

Adenocarcinoma

Adenocarcinoma, Papillary

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

During the surgical procedure, there was no occurrence of a decrease in recurrent laryngeal nerve signals or a decrease of less than 10%.

During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 10-50%.

During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 50-90%.

During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by more than 90% or completely disappeared.

The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.

Traditional thyroid surgery.

Bo Wang Professor, MD

Bo Wang Porfessor, MD

Bo Wang, MD

This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. The goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.

This research project conducts a detailed exploration into the fluctuations of intraoperative recurrent laryngeal nerve monitoring signals during thyroid surgery and their subsequent effects on the voice quality of patients after surgery. The study meticulously analyzes a comprehensive dataset comprised of surgical records and voice analyses conducted before and after the procedure. The primary objective is to pinpoint specific trends and changes in the nerve monitoring signals and to determine how these alterations correlate with the postoperative acoustic characteristics of patients' voices. By establishing a clear link between intraoperative signal dynamics and postoperative voice outcomes, the investigation aims to advance the field of thyroid surgery. This includes providing surgeons with critical insights for the precise evaluation of recurrent laryngeal nerve functionality, enabling targeted interventions during operations, and ultimately contributing to the enhancement of patients' quality of life following surgery. Through this rigorous analysis, the study seeks to contribute valuable knowledge to the surgical community, facilitating improved patient care and outcomes in thyroid surgery.

Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery

Recording intraoperative electromyographic signals, including vagus nerve V1 and V2 signals, recurrent laryngeal nerve R1 and R2 signals.

Recording data(SPL) of voice tests before and after the surgery, sound pressure level in dB(A)

Recording data(F0) of voice tests before and after the surgery, F0 in Hz

Recording data(Jitter) of voice tests before and after the surgery, Jitter in percentage

Recording data(Shimmer) of voice tests before and after the surgery, Shimmer in percentage

Conducted by an otolaryngologist, the RBH assessment includes R (Roughness), B (Breathiness), and H (Hoarseness).

Voice Handicap Index, including a scale with 30 items.The full, non-abbreviated title of the VHI-30 scale is the "Voice Handicap Index-30," and it is translated as the "Voice Disorder Severity Index." The scale ranges from a minimum score of 0 to a maximum of 120, with higher scores indicating poorer outcomes.

Recorded width of the recurrent laryngeal nerve in millimeters.

Note if the recurrent laryngeal nerve branches.

If there are branches in the recurrent laryngeal nerve, record the number of branches.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.	NCT04842994	Malignant Neopl...	IONM tube	-	Tata Memorial Hospital
Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery	NCT06254859	Thyroid Cancer Thyroid Cancer,...	Traditional thy...	-	Fujian Medical University

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