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Dr. Randolph’s Elsevier Author's Bio Page"
Practice Activities:
My clinical activity involves exclusively thyroid and parathyroid surgery with a yearly caseload at MEEI and MGH of approximately 300 endocrine surgical cases/year. Thyroid and parathyroid surgical volume at MEEI has grown several thousand percent as my practice has grown from the early 1990’s where less than 10 where performed per year. Thyroid cases are referred to my office primarily from endocrinologists as well as general surgical and head and neck surgeon colleagues. Typically, patients referred include patients with thyroid carcinoma with nodal disease, patients requiring revision thyroid cancer surgery, large or substernal goiters, patients requiring thyroidectomy who have one recurrent laryngeal nerve previously injured and patients requiring thyroid surgery who use their voice professionally. My practice involves a substantial amount of revision surgery referred from outside facilities and we have recently published on our successful treatment of this tertiary care thyroid cancer population. Algorithms for both neural monitoring and for preoperative nodal radiographic assessment of patients with papillary cancer of the thyroid have been generated, and published and are followed in our thyroid unit. I believe the value of my clinical practice to the institution at which I primarily work is reflected in the multiple hospital committee roles I have been assigned over the years, including recent election as President of the Joint Medical Staff of the MEEI, and Director of two departmental/MEEI divisions: the General Otolaryngology Division and the Thyroid and Parathyroid Surgical Division. I was appointed Surgeon in Otolaryngology in 2005.
Clinical Innovations:
Recurrent laryngeal nerve monitoring and management during thyroid surgery
A major focus of my research and clinical education is intraoperative recurrent laryngeal nerve and vagal monitoring during thyroid and parathyroid surgery (IONM). At MEEI in the late 90s I developed and maintain a clinical intraoperative neural monitoring program involving anesthesia, audiology and otolaryngology which provides electrophysiologic neural monitoring during thyroid and parathyroid surgery. As of June 2012 this program completed its 3000th neural monitoring case and is open to all members of the MEEI surgical community. As a result of this experience I recently formulated published guidelines and was the lead author on a publication on international neural monitoring guidelines (CV ref # 38). We have developed and published on canine and porcine electrophysiologic models of RLN injury (CV ref # 20, 23, 25).
I have been a strong advocate for intraoperative neural monitoring throughout the US and abroad and have seen neural monitoring, in part due to my work, increasingly utilized over the past decade. National and international surgical interest in neural monitoring has been intense over the last decade and has resulted in numerous invited and named lectureships requested from me on the topic of neural monitoring. It should be noted that while many studies evaluating IONM show divergent results in terms of rates of vocal cord paralysis with and without IONM these studies are significantly affected by problems of adequate power given the low rates of RLN paralysis at thyroid surgery. This issue has been addressed by Dralle and coworkers who have noted that an adequately powered study would require 9 million patients per arm for benign multinodular goiter and 40,000 patients per arm for thyroid malignancy surgery and so such a study that will never be performed (Dralle, Sekulla et al. 2004). IONM has now been shown in a randomized trial to reduce the rates of transient paralysis (Barczynski, Konturek et al. 2009), improve outcomes in high risk thyroid surgery for thyroid cancer and retrosternal goiter (Chan, Lang et al. 2006), reduce time to nerve identification (Sari S, Erbil Y, Sumer A, et al Int J Surg.8(6):474-478) and has been shown to significantly reduce the risk of bilateral nerve paralysis through neural testing prognostication of postop neural function, perhaps its most important IONM application (CV # 48, 59(Goretzki, Schwarz et al. 2010)).
Rates of IONM use have increased substantially over the last decade in part due to my work in peer reviewed literature as well as through my lectures nationally and abroad, my book chapters on the subject and my own text. IONM is current used in approximately 65% of thyroid surgery performed by head neck surgeons and over 50% of general surgeons in the US and is used more commonly by surgeons with higher surgical volume (Sturgeon, Sturgeon et al. 2009, Singer, Rosenfeld et al. 2012).) In fact our recent MGH and MEEI thyroid/endocrine fellow survey suggest fellows who are exposed in thyroid surgical fellowship to attending surgeons who do not use IONM as well as to attending surgeons who routinely use IONM, in fact after their fellowship use IONM in 100% of cases (CV ref # 56). Of note currently at Mass General Hospital five of the seven endocrine surgeons currently use neural monitoring in all cases. Through our human case series, I have endeavored to define specific clinical surgical applications of neural monitoring and have in the past published on a simple laryngeal palpation method of neural monitoring (CV ref # 10) and have more recently published on detailed quantitative normative EMG intraoperative ranges that allow for prediction of postoperative normal vocal cord function (CV ref # 59). The superior laryngeal nerve is an additional important structure to preserve especially for professional voice users undergoing thyroidectomy. I recently published one of the first descriptions of the electrophysiology of the human superior laryngeal nerve (CV # 53). Also I am second author on an International Neural Monitoring Study Group paper on the first international guidelines on IONM of the superior laryngeal nerve monitoring which have incorporated our electrophysiologic superior laryngeal nerve data (CV # 57). I have published in conjunction with surgical colleagues from Germany one of the first continuous vagal monitoring series a new novel form of neural monitoring which provides latency and amplitude correlates of impending nerve injury. This work on continuing vagal monitoring work may allow us for the first time with neural monitoring to prevent neural injury during surgery by identifying the earliest EMG signs of impending neuropraxic injury (CV # 48). Work on this novel form of neural monitoring to prevent nerve injury is ongoing and we are currently analyzing a larger series of patients to improve our ability to identify the earliest forms of EMG intraoperative neuropraxic injury during thyroid surgery.
In part as a result of the impact of my work through the peer-reviewed literature, book chapters, my text and numerous lectures in the US and abroad neural monitoring has become increasingly accepted. Currently German Association of Endocrine Surgery guidelines and the International Neural Monitoring Study Group both describe neural monitoring as necessary in all cases of thyroid and parathyroid surgery (CV # 38, (Musholt, Clerici et al. 2011). Recently published American Academy of Otolaryngology Head and Neck Surgery (AAOHNS) and American Head and Neck Society (AHNS) thyroid surgery guidelines in press , both of which I helped to author, for the first time also suggest neural monitoring has clear utility in neural identification, reduction of transient nerve paralysis rates, prognostication of nerve function and avoidance of bilateral cord paralysis. IONM is therefore recommended by these large surgical organizations as an option during thyroid and parathyroid surgery especially in bilateral thyroid surgery, revision thyroid cancer surgery or surgery involving and only functional nerve (CV # 55, 60). Recently published ATA Surgical Affairs Committee Consensus Statement on Outpatient Thyroid Surgery notes neural monitoring can be helpful in confirming intact neural function at the end of surgery and that this information may impact on discharge planning especially if the loss of signal is bilateral (Terris et al in press Thyroid).
Laryngeal exam prior to thyroid surgery
Closely linked to my neural monitoring work is the associated topic of the perioperative laryngeal exam. I have contributed in these areas with published clinical research on the practical importance of laryngeal information around the time of thyroid surgery (CV ref #11) and have brought the clinical message through multiple lectures in the US and abroad and also to both medical endocrinology and general surgical communities through editorials in both medical endocrinology journals (Thyroid) and the general surgical literature at (World Journal of Endocrine Surgery) (CV other peer reviewed #4, 5). I have been an invited lecture and advisor to the Scandinavian Quality Registry regarding the incorporation of voice and laryngeal exam data fields in their registry which is the largest endocrine surgical outcome registry in the world including national endocrine surgical databanks of Sweden, Norway and Denmark. In the 2008 report of the Scandinavian Quality register I am described as “perhaps the most distinguished authority in the field [of neural injury in association with thyroid surgery]". This work is ongoing. I have had leadership roles in both AAOHNS and AHNS laryngeal exam guidelines around the time of thyroid surgery (CV # 55, 60). American Thyroid Association recently published guidelines on anaplastic carcinoma and recent NCCN guidelines have adopted this information and recommend laryngeal exam prior to thyroid cancer surgery. The British Association of Endocrine and Thyroid Surgeons have also come to recommend routine laryngeal exam in part due to my work. Interest in this work has been intense nationally and internationally among both the otolaryngology and general surgical communities. I have been an invited lecturer on voice preservation and the importance of laryngeal exam at the Mayo Clinic, MD Anderson Cancer Center, Memorial Sloan-Kettering cancer center and Johns Hopkins Hospital and have been honored to give the following named lectureships around the world on these topics including: the UK Royal Society of Medicine Invited speaker on Thyroid Surgery and Voice, the George Choa Visiting Professor lectureship Dept. of Surgery, Li Ka Shing Faculty of Medicine, University of Hong Kong, the European Society of Endocrine Surgery Charles Proye Lecture, Gothenburg, the British Association of Endocrine and Thyroid Surgeons, British Journal of Surgery Lecture Cardiff, UK, the Anisio Costa Toledo Guest Invited Keynote lecturer on Thyroid and Voice, Sao Paolo Brazil , the European Association of Endocrine Surgeons Invited State of the Art moderator and lecturer on IONM in Thyroid Cancer, and the Annual Morley Binstock University of Toronto/ Mt Sinai Hospital Lectureship in Head and Neck Oncology.