Update on Regulation of Regenerative Medicine in Taiwan.

Due to rapid development of biotechnology in recent years, the field of regenerative medicine has attracted considerable attention. Regenerative medicine-related regulations have been established in several countries to ensure the quality, safety, and efficacy of innovative treatments. Considering the diversity of regenerative medicine, the regulatory framework in Taiwan has been adjusted in response to global trend and local demand.

Investigation of the Electrophysiological and Thermographic Safety Parameters of Surgical Energy Devices during Thyroid and Parathyroid Surgery in a Porcine Model.

In thyroid and parathyroid surgery, surgical energy devices (SEDs) provide more efficient hemostasis than conventional clamp-and-tie hemostasis in areas with rich blood supply. However, when a SED is activated near the recurrent laryngeal nerve (RLN), the heat generated by the SED may injure the nerve irreversibly. To safely apply SEDs in thyroid/parathyroid surgery, this article introduces experimental porcine model studies to investigate the activation and cooling safety parameters of SEDs in standardized electrophysiological (EP) and thermographic (TG) procedures, respectively.

Safety Parameters of Quantum Molecular Resonance Devices During Thyroid Surgery: Porcine Model Using Continuous Neuromonitoring.

Objectives: Quantum molecular resonance (QMR) devices have been applied as energy-based devices in many head and neck surgeries; however, research on their use in thyroid surgery is lacking. This study aimed to investigate the safety parameters of QMR devices during thyroidectomy when dissection was adjacent to the recurrent laryngeal nerve (RLN).

Methods: This study included eight piglets with 16 RLNs, and real-time electromyography (EMG) signals were obtained from continuous intraoperative neuromonitoring (C-IONM).

Accumulation of Experience and Newly Developed Devices Can Improve the Safety and Voice Outcome of Total Thyroidectomy for Graves' Disease.

Total thyroidectomy (TT) in patients with Graves' disease is challenging even for an experienced thyroid surgeon. This study aimed to investigate the accumulation of experience and applying newly developed devices on major complications and voice outcomes after surgery of a single surgeon over 30 years. This study retrospectively reviewed 90 patients with Graves' disease who received TT.

A Surgeon-Centered Neuromuscular Block Protocol Improving Intraoperative Neuromonitoring Outcome of Thyroid Surgery.

Background: Neuromuscular blocking agents provide muscular relaxation for tracheal intubation and surgery. However, the degree of neuromuscular block may disturb neuromuscular transmission and lead to weak electromyography during intraoperative neuromonitoring. This study aimed to investigate a surgeon-friendly neuromuscular block degree titrated sugammadex protocol to maintain both intraoperative neuromonitoring quality and surgical relaxation during thyroid surgery.

Correlation between Electrophysiological Change and Facial Function in Parotid Surgery Patients.

This observational study investigated intraoperative electrophysiological changes and their correlation with postoperative facial expressions in parotidectomy patients with visual confirmation of facial nerve (FN) continuity. Maximal electromyography(EMG) amplitudes of the facial muscles corresponding to temporal, zygomatic, buccal and mandibular branches were compared before/after FN dissection, and facial function at four facial regions were evaluated before/after parotidectomy in 112 patients. Comparisons of 448 pairs of EMG signals revealed at least one signal decrease after FN dissection in 75 (67%) patients.

Prognostic Indicators of Non-Transection Nerve Injury and Vocal Fold Motion Impairment After Thyroid Surgery - Correlation Between Intraoperative Neuromonitoring Findings and Perioperative Voice Parameters.

Objectives: In patients with recurrent laryngeal nerve (RLN) injury after thyroid surgery, unrecovered vocal fold motion (VFM) and subjective voice impairment cause extreme distress. For surgeons, treating these poor outcomes is extremely challenging. To enable early treatment of VFM impairment, this study evaluated prognostic indicators of non-transection RLN injury and VFM impairment after thyroid surgery and evaluated correlations between intraoperative neuromonitoring (IONM) findings and perioperative voice parameters.

Improving Voice Outcomes After Thyroid Surgery - Review of Safety Parameters for Using Energy-Based Devices Near the Recurrent Laryngeal Nerve.

Technological advances in thyroid surgery have rapidly increased in recent decades. Specifically, recently developed energy-based devices (EBDs) enable simultaneous dissection and sealing tissue. EBDs have many advantages in thyroid surgery, such as reduced blood loss, lower rate of post-operative hypocalcemia, and shorter operation time.

Comparison of Clinical Outcomes of Radical Prostatectomy versus IMRT with Long-Term Hormone Therapy for Relatively Young Patients with High- to Very High-Risk Localized Prostate Cancer.

That intensity-modulated radiotherapy (IMRT) plus antiandrogen therapy (IMRT-ADT) and radical prostatectomy (RP) are the definitive optimal treatments for relatively young patients (aged ≤ 65 years) with high- or very high-risk localized prostate cancer (HR/VHR-LPC), but remains controversial. We conducted a national population-based cohort study by using propensity score matching (PSM) to evaluate the clinical outcomes of RP and IMRT-ADT in relatively young patients with HR/VHR-LPC. : We used the Taiwan Cancer Registry database to evaluate clinical outcomes in relatively young (aged ≤ 65 years) patients with HR/VHR-LPC, as defined by the National Comprehensive Cancer Network risk strata.

Correlation Between Objective and Subjective High-Pitched Voice Impairment in Patients After Thyroid Surgery.

Objectives: High-pitched voice impairment (HPVI) is not uncommon in patients without recurrent laryngeal nerve (RLN) or external branch of superior laryngeal nerve (EBSLN) injury after thyroidectomy. This study evaluated the correlation between subjective and objective HPVI in patients after thyroid surgery.

Methods: This study analyzed 775 patients without preoperative subjective HPVI and underwent neuromonitored thyroidectomy with normal RLN/EBSLN function.

New Developments in Anterior Laryngeal Recording Technique During Neuromonitored Thyroid and Parathyroid Surgery.

A recurrent laryngeal nerve (RLN) injury resulting in vocal fold paralysis and dysphonia remains a major source of morbidity after thyroid and parathyroid surgeries. Intraoperative neural monitoring (IONM) is increasingly accepted as an adjunct to the standard practice of visual RLN identification. Endotracheal tube (ET) surface recording electrode systems are now widely used for IONM; however, the major limitation of the clinical use of ET-based surface electrodes is the need to maintain constant contact between the electrodes and vocal folds during surgery to obtain a high-quality recording.

How the Severity and Mechanism of Recurrent Laryngeal Nerve Dysfunction during Monitored Thyroidectomy Impact on Postoperative Voice.

Intraoperative neuromonitoring can qualify and quantify RLN function during thyroid surgery. This study investigated how the severity and mechanism of RLN dysfunction during monitored thyroid surgery affected postoperative voice. This retrospective study analyzed 1021 patients that received standardized monitored thyroidectomy.

Laryngeal Neural Monitoring during Pediatric Thyroid Cancer Surgery-Is Transcartilage Recording a Preferable Method?

The use of transcartilage (TC) intraoperative neuromonitoring (IONM) in a pediatric population has not been reported. This study evaluated the feasibility and the benefit of using TC-IONM for thyroid cancer surgery in a pediatric population. This retrospective single-center study enrolled 33 pediatric patients who had received an IONM-assisted thyroidectomy.

Comparison of Surgical Complications Rates Between LigaSure Small Jaw and Clamp-and-Tie Hemostatic Technique in 1,000 Neuro-Monitored Thyroidectomies.

Over the past decade, the use of neuromonitoring in thyroid surgery has become well established and is increasing accepted across the world. In addition, new developments in energy devices have significantly improved efficacy in achieving hemostasis in thyroid surgery. Few studies focused on the complication rates in energy device-assisted sutureless neuro-monitored thyroidectomy.

Effects of 1-Year Hospital Volume on Surgical Margin and Biochemical-Failure-Free Survival in Patients Undergoing Robotic versus Nonrobotic Radical Prostatectomy: A Nationwide Cohort Study from the National Taiwan Cancer Database.

Purpose: To examine the effect of hospital volume on positive surgical margin (PSM) and biochemical-failure-free survival (BFS) rates in patients with prostate cancer (PC) undergoing robotic-assisted or nonrobotic-assisted radical prostatectomy (RP).

Patients And Methods: The patients were men collected in the National Taiwan Cancer Registry diagnosed as having PC without distant metastasis who received RP from 44 multi-institutes in Taiwan. The logistic regression method was used to analyze the risk from RP to PSM in included patients with hospital volume (i.

Full percutaneous intraoperative neuromonitoring technique in remote thyroid surgery: Porcine model feasibility study.

Background: In remote thyroid surgery, a reliable intraoperative neuromonitoring (IONM) procedure is an important tool for reducing injury to recurrent laryngeal nerve (RLN). This study proposes an alternative or adjunct technique for performing full percutaneous (PC) IONM and confirms its feasibility in animal experiments.

Methods: This prospective porcine model study enrolled four piglets with eight nerve sides.

Precision Neuromuscular Block Management for Neural Monitoring During Thyroid Surgery.

Introduction: Titration of neuromuscular block (NMB) plays a key role in intraoperative recurrent laryngeal nerve monitoring during thyroid surgery. The combination of neuromuscular blocking agent and timely partial reversal of NMB was investigated in both animal experiments and clinical neuro-monitored thyroidectomy.

Methods: In animal experiments, 8 piglets received sugammadex to assess the laryngeal EMG recovery after rocuronium-induced NMB.

Safety of Ligasure exact dissector in thyroidectomy with continuous neuromonitoring: a porcine model.

Background: The purpose of this study was to investigate and define safety parameters for using the Ligasure exact dissector (LED) for dissection close to the recurrent laryngeal nerve (RLN) during thyroidectomy.

Methods: Real-time electrophysiologic electromyographic (EMG) tracings were recorded in 16 RLNs (8 piglets) during various applications of LED under continuous intraoperative monitoring in this prospective porcine model study. In the activation study, LED was activated at varying distances from the RLN.

Safety parameters of ferromagnetic device during thyroid surgery: Porcine model using continuous neuromonitoring.

Background: The ferromagnetic (FM) device is a new surgical energy modality. This study investigated dynamic recurrent laryngeal nerve (RLN) electromyographic (EMG) data to define safety parameters for using FM devices in thyroidectomy.

Methods: Real-time EMG tracings obtained under continuous neuromonitoring were recorded from 24 RLNs (12 piglets).

Comparison of hypocalcemia rates between LigaSure and clamp-and-tie hemostatic technique in total thyroidectomies.

Background: Postoperative hypocalcemia (PH) is a serious complication after total thyroidectomy. This study aimed to compare PH rates between LigaSure Small Jaw (LSJ) and clamp-and-tie hemostatic technique in patients undergoing total thyroidectomy.

Methods: Four hundred twenty patients were divided into two groups: group L (210 patients) performed with LSJ and group C (210 patients) with clamp-and-tie technique.

Intra-Operative Neural Monitoring of Thyroid Surgery in a Porcine Model.

Intraoperative injury to the recurrent laryngeal nerve (RLN) can cause vocal cord paralysis, which interferes with speech and can potentially interfere with breathing. In recent years, intraoperative neural monitoring (IONM) has been widely adapted as an adjunct technique to localize the RLN, detect RLN injury, and predict vocal cord function during the operations. Many studies have also used animal models to investigate new applications of IONM technology and to develop reliable strategies for preventing intraoperative RLN injury.

Feasibility of Intraoperative Neuromonitoring During Thyroid Surgery Using Transcartilage Surface Recording Electrodes.

Background: Intraoperative neural monitoring (IONM) has gained widespread acceptance as an adjunct to the gold standard of visual identification of the recurrent laryngeal nerve (RLN) during thyroid surgery. Currently, laryngeal electromyography (EMG) recording during IONM is almost always performed using endotracheal tube (ETT) surface electrodes placed adjacent to vocal folds originating from the inner surface of the thyroid cartilage (TC). Therefore, it was hypothesized that surface recording electrodes placed on the outer surface of the TC should enable access to the EMG response of the vocal folds during IONM.

Transcutaneous Recording During Intraoperative Neuromonitoring in Thyroid Surgery.

Background: Recurrent laryngeal nerve (RLN) palsy remains a major source of morbidity after thyroid surgeries. Intraoperative neural monitoring (IONM) has gained increasing acceptance as an adjunct to standard practice of visual RLN identification. Endotracheal tube (ETT) surface recording electrodes systems are now widely used for IONM; however, a malpositioned ETT can cause false IONM results and requires time-consuming intraoperative verification of the ETT position and readjustment by the anesthesiologist.