Base of the tongue hyalinizing clear cell carcinoma: Case report and literature review.

Hyalinizing clear cell carcinoma is an uncommon neoplasm arising in minor salivary glands. We present a rare case of hyalinizing clear cell carcinoma in the base of the tongue. We report a case of a 38-year-old female presented with a progressive history of hemoptysis and dysphagia over the course of 4 years. Examination revealed a mass originating from the base of the tongue with a biopsy confirmed as hyalinizing clear cell carcinoma . An Ovid MEDLINE and PubMed literature review was conducted due to the rarity of this type of tumor. The patient underwent surgical excision with immediate reconstruction with radial forearm free flap followed with adjuvant radiotherapy and was disease free at her most recent follow-up (12 months). Our review included a total of 13 new cases, including our case. The majority of the cases presented with dysphagia. Surgical excision is the mainstay of treatment, and overall these patients have a good prognosis. Our case highlights a rare presentation of hyalinizing clear cell carcinoma of the base of the tongue, successfully treated with surgical excision, free tissue reconstruction and adjuvant radiotherapy.

Implementation, results and face validity of the Consultation and Relational Empathy measure in a Canadian department of surgery.

BACKGROUND: The Consultation and Relational Empathy (CARE) Measure, a validated questionnaire designed to assess patients' perceptions of their physician's communication skills and empathy, has been used to assess empathy in medical specialties but has seldom been applied to surgery. We assessed empathy and communication skills among a group of surgeons within a single academic institution. METHODS: All surgeons within our department of surgery were invited to participate. Patients seen in clinics of participating surgeons were recruited prospectively from July 2018 to February 2019. At the end of each clinical encounter, they were asked to complete a CARE survey. Surveys were analyzed according to previously validated inclusion and exclusion criteria. We calculated mean scores for each surgeon and surgical division. About 6 months after study completion, surgeons were provided with their individual score and de-identified division scores, and were asked to complete a follow-up survey assessing their attitudes toward the CARE Measure. RESULTS: Of the 82 surgeons invited, 51 (62%) agreed to participate; 7 had fewer than 25 completed surveys and were excluded from analysis. A total of 1801 surveys for 44 surgeons (33 male and 11 female) were included in the final analysis. The average CARE score across the department was 46.9 (95% confidence interval [CI] 46.6-47.1). Female surgeons received significantly higher scores than male surgeons (mean 47.6 [95% CI 47.1-48.0] v. 46.7 [95% CI 46.4-48.0]). Of the 35 surgeons who responded to the follow-up survey, 31 (89%) felt that the questions in the CARE Measure applied to their practice, and half of these reported that they intended to make changes in response to the feedback. CONCLUSION: We found high communication and empathy scores among surgeons in the outpatient setting, with enough variability to encourage continued improvement. The CARE Measure appears to have face validity among surgeons, and the vast majority found it relevant to their practice. Further study is needed to formally assess the relevance, performance, reliability and construct validity of this measure.

Assessment of Toxic Effects and Survival in Treatment Deescalation With Radiotherapy vs Transoral Surgery for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: The ORATOR2 Phase 2 Randomized Clinical Trial.

Importance: The optimal approach for treatment deescalation in human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) is unknown. Objective: To assess a primary radiotherapy (RT) approach vs a primary transoral surgical (TOS) approach in treatment deescalation for HPV-related OPSCC. Design, Setting, and Participants: This international, multicenter, open-label parallel-group phase 2 randomized clinical trial was conducted at 9 tertiary academic cancer centers in Canada and Australia and enrolled patients with T1-T2N0-2 p16-positive OPSCC between February 13, 2018, and November 17, 2020. Patients had up to 3 years of follow-up. Interventions: Primary RT (consisting of 60 Gy of RT with concurrent weekly cisplatin in node-positive patients) vs TOS and neck dissection (ND) (with adjuvant reduced-dose RT depending on pathologic findings). Main Outcomes and Measures: The primary end point was overall survival (OS) compared with a historical control. Secondary end points included progression-free survival (PFS), quality of life, and toxic effects. Results: Overall, 61 patients were randomized (30 [49.2%] in the RT arm and 31 [50.8%] in the TOS and ND arm; median [IQR] age, 61.9 [57.2-67.9] years; 8 women [13.6%] and 51 men [86.4%]; 31 [50.8%] never smoked). The trial began in February 2018, and accrual was halted in November 2020 because of excessive toxic effects in the TOS and ND arm. Median follow-up was 17 months (IQR, 15-20 months). For the OS end point, there were 3 death events, all in the TOS and ND arm, including the 2 treatment-related deaths (0.7 and 4.3 months after randomization, respectively) and 1 of myocardial infarction at 8.5 months. There were 4 events for the PFS end point, also all in the TOS and ND arm, which included the 3 mortality events and 1 local recurrence. Thus, the OS and PFS data remained immature. Grade 2 to 5 toxic effects occurred in 20 patients (67%) in the RT arm and 22 (71%) in the TOS and ND arm. Mean (SD) MD Anderson Dysphagia Inventory scores at 1 year were similar between arms (85.7 [15.6] and 84.7 [14.5], respectively). Conclusions and Relevance: In this randomized clinical trial, TOS was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year. Long-term follow-up is required to assess OS and PFS outcomes. Trial Registration: Clinicaltrials.gov Identifier: NCT03210103.

Randomized Trial of Radiotherapy Versus Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma: Long-Term Results of the ORATOR Trial.

PURPOSE: The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has risen rapidly, because of an epidemic of human papillomavirus infection. The optimal management of early-stage OPSCC with surgery or radiation continues to be a clinical controversy. Long-term randomized data comparing these paradigms are lacking. METHODS: We randomly assigned patients with T1-T2, N0-2 (≤ 4 cm) OPSCC to radiotherapy (RT) (with chemotherapy if N1-2) versus transoral robotic surgery plus neck dissection (TORS + ND) (with or without adjuvant therapy). The primary end point was swallowing quality of life (QOL) at 1-year using the MD Anderson Dysphagia Inventory. Secondary end points included adverse events, other QOL outcomes, overall survival, and progression-free survival. All analyses were intention-to-treat. Herein, we present long-term outcomes from the trial. RESULTS: Sixty-eight patients were randomly assigned (n = 34 per arm) between August 10, 2012, and June 9, 2017. Median follow-up was 45 months. Longitudinal MD Anderson Dysphagia Inventory analyses demonstrated statistical superiority of RT arm over time (P = .049), although the differences beyond 1 year were of smaller magnitude than at the 1-year timepoint (year 2: 86.0 ± 13.5 in the RT arm v 84.8 ± 12.5 in the TORS + ND arm, P = .74; year 3: 88.9 ± 11.3 v 83.3 ± 13.9, P = .12). These differences did not meet the threshold to qualify as a clinically meaningful change at any timepoint. Certain differences in QOL concerns including more pain and dental concerns in the TORS + ND arm seen at 1 year resolved at 2 and 3 years; however, TORS patients started to use more nutritional supplements at 3 years (P = .015). Dry mouth scores were higher in RT patients over time (P = .041). CONCLUSION: On longitudinal analysis, the swallowing QOL difference between primary RT and TORS + ND approaches persists but decreases over time. Patients with OPSCC should be informed about the pros and cons of both treatment options (ClinicalTrials.gov identifier: NCT01590355).

Comparison of diagnostic accuracy of computed tomography virtual endoscopy and flexible fibre-optic laryngoscopy in the evaluation of neck anatomic structures and neoplasms.

BACKGROUND AND PURPOSE: Computed tomography virtual endoscopy (CT-VE) is a non-invasive technique which allows visualisation of intraluminal surfaces by tridimensional reconstruction of air/soft tissues. The aim of this study was to compare the diagnostic accuracy of CT-VE and flexible fibre-optic laryngoscopy (FFL) in identifying normal neck anatomic structures and pharyngeal and laryngeal lesions. METHODS: Forty-two patients with a history of neck cancer were assessed by two ENT surgeons using FFL and by one neuroradiologist using CT-VE in order to evaluate the visualisation of the epiglottis, vallecula, glossoepiglottic folds, pyriform sinuses, vocal cords and mass pathology. The visualisation of the structures in both modalities was assessed according to the following score: 0 = not visualised, 1 = partial visualisation, 2 = complete and clear visualisation. A weighted kappa coefficient was used to evaluate the inter-observer agreement. McNemar's test was performed to compare the two diagnostic tests. RESULTS: The inter-observer agreement between FFL and CT-VE was fair in the assessment of the vocal cords (k = 0.341); moderate in the assessment of the glossoepiglottic folds (k = 0.418), epiglottis (k = 0.513) and pyriform sinuses (k = 0.477); and substantial in the assessment of the vallecula (k = 0.618) and the tumour (0.740). McNemar's test showed no significant difference between the two tests (p<0.05). CONCLUSION: CT-VE is a non-invasive technique with a diagnostic accuracy comparable to FFL in terms of visualisation of anatomical structures and pharyngeal and laryngeal lesions.

A practical guide to optimizing the benefits of post-stroke spasticity interventions with botulinum toxin A: An international group consensus.

This consensus paper is derived from a meeting of an international group of 19 neurological rehabilitation specialists with a combined experience of more than 250 years (range 4-25 years; mean 14.1 years) in treating post-stroke spasticity with botulinum toxin A. The group undertook critical assessments of some recurring practical challenges, not yet addressed in guidelines, through an exten-sive literature search. They then discussed the results in the light of their individual clinical experience and developed consensus statements to present to the wider community who treat such patients. The analysis provides a comprehensive overview of treatment with botulinum toxin A, including the use of adjunctive therapies, within a multidisciplinary context, and is aimed at practicing clinicians who treat patients with post-stroke spasticity and require further practical guidance on the use of botulinum toxin A. This paper does not replicate information published elsewhere, but instead aims to provide practical advice to help optimize the use of botulinum toxin A and maximize clinical outcomes. The recommendations for each topic are summarized in a series of statements. Where published high-quality evidence exists, the recommendations reflect this. However, where evidence is not yet conclusive, the group members issued statements and, in some cas-es, made recommendations based on their clinical experience.

Quality Indicators of Central Compartment Neck Dissection in Thyroid Surgery.

OBJECTIVES: Quality metrics are an increasingly important means of improving patient care. Variability in the number of lymph nodes removed during central compartment lymph node dissection (CCLND) at the time of thyroidectomy has not been studied. STUDY DESIGN: A retrospective cohort study was performed using American College of Surgeons National Quality Improvement Program (ACS-NSQIP) data. SETTING: Centers in North America and worldwide contributing data to ACS-NSQIP and performing thyroidectomy on adults in inpatient and outpatient settings were included. SUBJECTS AND METHODS: Adult patients undergoing thyroidectomy with or without CCLND were included. Outcomes of interest were number of nodes removed during CCLND and risks of postoperative hypocalcemia. RESULTS: In total, 6108 patients met inclusion criteria (1565 with CCLND). The median number of lymph nodes removed during CCLND was 2. There was no statistically significant association between postoperative hypocalcemia and CCNLD, regardless of number of nodes removed. However, we were underpowered to detect this association based on the overall low nodal yield of many CCLNDs performed. CONCLUSION: In many cases where CCLND is documented as part of thyroidectomy, very few lymph nodes are removed. Our ability to draw conclusions regarding the effect of CCLND on postoperative hypocalcemia is restricted due to the limited nature of many CCLNDs performed.

Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial.

BACKGROUND: Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two de-escalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches. METHODS: This is a multicenter phase II study randomizing one hundred and forty patients with T1-2 N0-2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60 Gy) ± concomitant chemotherapy and TOS ± de-escalated adjuvant radiotherapy (50-60 Gy based on risk factors). Patients will be stratified based on smoking status (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity. DISCUSSION: This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.

Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial.

BACKGROUND: Transoral robotic surgery (TORS) with concurrent neck dissection has supplanted radiotherapy in the USA as the most common treatment for oropharyngeal squamous cell carcinoma (OPSCC), yet no randomised trials have compared these modalities. We aimed to evaluate differences in quality of life (QOL) 1 year after treatment. METHODS: The ORATOR trial was an investigator-initiated, multicentre, international, open-label, parallel-group, phase 2, randomised study. Patients were enrolled at six hospitals in Canada and Australia. We randomly assigned (1:1) patients aged 18 years or older, with Eastern Cooperative Oncology Group scores of 0-2, and with T1-T2, N0-2 (≤4 cm) OPSCC tumour types to radiotherapy (70 Gy, with chemotherapy if N1-2) or TORS plus neck dissection (with or without adjuvant chemoradiotherapy, based on pathology). Following stratification by p16 status, patients were randomly assigned using a computer-generated randomisation list with permuted blocks of four. The primary endpoint was swallowing-related QOL at 1 year as established using the MD Anderson Dysphagia Inventory (MDADI) score, powered to detect a 10-point improvement (a clinically meaningful change) in the TORS plus neck dissection group. All analyses were done by intention to treat. This study is registered with ClinicalTrials.gov (NCT01590355) and is active, but not currently recruiting. FINDINGS: 68 patients were randomly assigned (34 per group) between Aug 10, 2012, and June 9, 2017. Median follow-up was 25 months (IQR 20-33) for the radiotherapy group and 29 months (23-43) for the TORS plus neck dissection group. MDADI total scores at 1 year were mean 86·9 (SD 11·4) in the radiotherapy group versus 80·1 (13·0) in the TORS plus neck dissection group (p=0·042). There were more cases of neutropenia (six [18%] of 34 patients vs none of 34), hearing loss (13 [38%] vs five [15%]), and tinnitus (12 [35%] vs two [6%]) reported in the radiotherapy group than in the TORS plus neck dissection group, and more cases of trismus in the TORS plus neck dissection group (nine [26%] vs one [3%]). The most common adverse events in the radiotherapy group were dysphagia (n=6), hearing loss (n=6), and mucositis (n=4), all grade 3, and in the TORS plus neck dissection group, dysphagia (n=9, all grade 3) and there was one death caused by bleeding after TORS. INTERPRETATION: Patients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change. Toxicity patterns differed between the groups. Patients with OPSCC should be informed about both treatment options. FUNDING: Canadian Cancer Society Research Institute Grant (#701842), Ontario Institute for Cancer Research Clinician-Scientist research grant, and the Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers grant.

An aggressive central giant cell granuloma in a pediatric patient: case report and review of literature.

BACKGROUND: Central giant cell granulomas are benign tumours of the mandible, presenting in children and young adults. Divided into non- and aggressive subtypes, the aggressive subtype is relatively rare and can occasionally progress rapidly, resulting in significant morbidity. CASE PRESENTATION: We present a case of an aggressive central giant cell granuloma (CGCG) in a six year-old female. The lesion originated in the right mandibular ramus and progressed rapidly to involve the condyle. Diagnosis was made using a combination of imaging and pathology. A timely en bloc resection of the hemi-mandible was performed with placement of a reconstructive titanium plate and condylar prosthesis. CONCLUSION: Our case demonstrates the importance of considering CGCG in the differential diagnosis of rapidly progressive mandibular lesions in the pediatric population. Prompt diagnosis and management can greatly improve long-term outcomes.

American Head and Neck Society Endocrine Section clinical consensus statement: North American quality statements and evidence-based multidisciplinary workflow algorithms for the evaluation and management of thyroid nodules.

BACKGROUND: Care for patients with thyroid nodules is complex and multidisciplinary, and research demonstrates variation in care. The objective was to develop clinical guidelines and quality metrics to reduce unwarranted variation and improve quality. METHODS: Multidisciplinary expert consensus and modified Delphi approach. Source documents were workflow algorithms from Kaiser Permanente Northern California and Cancer Care of Ontario based on the 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer. RESULTS: A consensus-based, unified preoperative, perioperative, and postoperative workflow was developed for North American use. Twenty-one panelists achieved consensus on 16 statements about workflow-embedded process and outcomes metrics addressing safety, access, appropriateness, efficiency, effectiveness, and patient centeredness of care. CONCLUSION: A panel of Canadian and United States experts achieved consensus on workflows and quality metric statements to help reduce unwarranted variation in care, improving overall quality of care for patients diagnosed with thyroid nodules.

Can Thyroid Ultrasonography Predict Substernal Extension or Tracheal Compression in Goiters?

PURPOSE: To determine whether an ultrasonography (US)-defined thyroid volume can accurately predict substernal extension or tracheal narrowing. METHODS: After research ethics approval, we identified patients with thyroid nodules investigated with both US and computed tomography (CT). Reviewers assigned scores for both substernal extension and tracheal compression on CT using pre-established classification systems. Statistical analysis with receiver operating characteristic curve analysis was performed to find the US-determined thyroid volume thresholds that correlated with each substernal extension and tracheal compression. RESULTS: This study included 120 patients (mean age 63.4 years; SD ± 15.9; 67% female). Thirty-five patients (29%) had substernal extension. The mean US total thyroid gland volume in patients with and without substernal extension were 92.4 and 37.6 cm3, respectively (P < .001). 86% of patients with substernal extension had tracheal narrowing vs. 27% of patients without substernal extension (P < .0001). A cutoff dominant gland volume of ≥37.5 cm3 showed 83% sensitivity and 79% specificity for substernal extension (area under the curve [AUC] = 0.84). A total thyroid gland volume threshold of ≥37.8 cm3 showed 89% sensitivity and 87% specificity for any degree of tracheal narrowing (AUC = 0.90). CONCLUSIONS: This study suggests that US volumes may be used as a predictor to identify those patients with thyroid enlargement who are most at risk of substernal extension and tracheal compression and who may benefit from preoperative CT imaging for optimal surgical and anesthetic planning.

Effect of Implementing Community of Practice Modified Thyroid Imaging Reporting and Data System on Reporting Adherence and Number of Thyroid Biopsies.

RATIONALE AND OBJECTIVES: Thyroid nodules are common in the population, although the rate of malignancy is relatively low (5%-15%). The purpose of this study was to determine if introducing a modified standardized reporting format and management algorithm (Thyroid Imaging Reporting and Data System [TI-RADS]) affects radiologist reporting adherence, number of thyroid biopsies, and other measurable outcomes. MATERIALS AND METHODS: All thyroid biopsies performed over two 6-month periods were evaluated at a tertiary care hospital with Research Ethics Board approval. The first period was before implementation of TI-RADS and the second was several months after implementation of TI-RADS (using a modified version made through a multidisciplinary collaboration). The number of biopsies performed was determined in each of the two periods as well as the percent of positive malignancy, wait times, and rates of non-diagnostic/unsatisfactory and inconclusive biopsies, which included atypia of undetermined significance (AUS) and follicular lesion of undetermined significance (FLUS). RESULTS: The average number of biopsies performed prior to implementing modified Kwak's TI-RADS was 74 thyroid biopsies per month and the average number of diagnostic ultrasounds was 271. After the introduction of modified Kwak's TI-RADS, the average number of thyroid biopsies decreased to 60 per month (an 18.9% reduction, P < .05), and the number of diagnostic ultrasound increased to 287 per month (a 5.9% increase from 2016 to 2017). The average wait time for a thyroid biopsy decreased from 5 to 3 weeks (P < .05). There was a slight increase in the rate of positive malignancy results (from 15% to 18%), although it was not statistically significant. The rate of non-diagnostic/unsatisfactory and inconclusive results (including AUS and FLUS) remained unchanged (18% AUS/FLUS/15% non-diagnostic/unsatisfactory before and 17% AUS/FLUS/15% non-diagnostic/unsatisfactory after TI-RADS introduction, P > .05). CONCLUSIONS: Introduction of a multidisciplinary-approved standardized reporting system with evidence-based management recommendations led to no statistically significant change in the number of diagnostic ultrasounds but a statistically significant reduction in the number of monthly thyroid biopsies and associated reduction in wait times.

Selectively false-positive radionuclide scan in a patient with sarcoidosis and papillary thyroid cancer: a case report and review of the literature.

BACKGROUND: Radioiodine and Tc-99 m pertechnetate scans are routinely relied upon to detect metastasis in papillary thyroid cancer; false-positive scans are relatively rare. To our knowledge, no published reports exist of sarcoidosis causing such selectively false-positive scans. METHODS: We present a case of a 41-year-old woman with known metastatic papillary thyroid cancer (T1bN1aMx) in whom sarcoidosis-affected cervical and mediastinal lymph nodes demonstrated uptake of thyroid-targeting radionuclides. Only the minority of these nodes demonstrated radionuclide uptake, raising the suspicion of adjacent or coexisting sarcoid and metastatic involvement. Selective uptake of thyroid-targeted radionuclides by isolated sarcoidosis is, to our knowledge, a previously undocumented occurrence. RESULTS: Biopsies of uptake-negative mediastinal nodes revealed sarcoidosis. Pathology from a subsequent neck dissection excising uptake-positive cervical nodes also showed sarcoidosis, with no coinciding malignancy. CONCLUSIONS: We document a case of sarcoidosis causing a selectively false-positive thyroid scintigraphy scan. It is useful for clinicians to be aware of potential false-positives and deceptive patterns on radionuclide scans when managing patients with both well-differentiated thyroid cancer and a co-existing disease affecting the nodal basins draining the thyroid gland.

The effect of topically applied tissue expanders on radial forearm skin pliability: a prospective self-controlled study.

BACKGROUND: The use of pre-operatively applied topical tissue expansion tapes have previously demonstrated increased rates of primary closure of radial forearm free flap donor sites. This is associated with a reduced cost of care as well as improved cosmetic appearance of the donor site. Unfortunately, little is known about the biomechanical changes these tapes cause in the forearm skin. This study tested the hypothesis that the use of topically applied tissue expansion tapes will result in an increase in forearm skin pliability in patients undergoing radial forearm free flap surgery. METHODS: Twenty-four patients scheduled for head and neck surgery requiring a radial forearm free flap were enrolled in this prospective self-controlled observational study. DynaClose tissue expansion tapes (registered Canica Design Inc, Almonte, Canada) were applied across the forearm one week pre-operatively. Immediately prior to surgery, the skin pliability of the dorsal and volar forearm sites were measured with the Cutometer MPA 580 (registered Courage-Khazaka Electronic GmbH, Cologne, Germany) on both the treatment and contralateral (control) arms. Paired t-tests were used to compare treatment to control at both sites, with p < 0.025 defined as statistically significant. RESULTS: There was a statistically significant increase in pliability by a mean of 0.05 mm (SD = 0.09 mm) between treatment and control arms on the dorsal site (95% CI [0.01, 0.08], p = 0.018). This corresponded to an 8% increase in pliability. In contrast, the volar site did not show a statistically significant difference between treatment and control (mean difference = 0.04 mm, SD = 0.20 mm, 95% CI [-0.04, 0.12], p = 0.30). CONCLUSIONS: This result provides evidence that the pre-operative application of topical tissue expansion tapes produces measurable changes in skin biomechanical properties. The location of this change on the dorsal forearm is consistent with the method of tape application. While this increase in skin pliability may account for the improved rate of primary donor site closure reported using this technique, the results did not reach our definition of clinical significance.

Development of a transoral robotic surgery program in Canada.

Due to significant differences in healthcare structure between the United States and Canada, there are unique barriers to adopting new medical technology in Canada. In this article, we describe our experience developing a transoral robotic surgery (TORS) program at Western University. Specifically, we outline the steps that were necessary to obtain institutional and multidisciplinary team approval, financial support, as well as surgeon and allied healthcare personnel training. This experience can potentially be used as a roadmap for other Canadian institutions pursuing a TORS program.

Management of the radial forearm free flap donor site using a topically applied tissue expansion device.

BACKGROUND: The purpose of this study was to prospectively assess clinical outcomes in patients undergoing a new method of donor site management for radial forearm free flaps. METHODS: 177 patients underwent reconstruction of ablative defects of the head and neck using a radial forearm free-flap. All patients had topical tissue expansion tapes applied to their forearms preoperatively. Closure rates, healing time and complications associated with the technique were assessed. RESULTS: Ninety-five percent of patients had their donor sites closed primarily with a locally harvested full thickness skin graft. Complications related to the tissue expansion device included a loss of device adhesion (19.3%) requiring reapplication and minor pruritic reactions (4.1%). CONCLUSIONS: This system of donor site management has resulted in a significant reduction in the requirement of a split thickness skin graft for coverage of the donor site in a radial forearm free flap without any significant economic cost or patient morbidity.

Early-stage squamous cell carcinoma of the oropharynx: radiotherapy vs. trans-oral robotic surgery (ORATOR)--study protocol for a randomized phase II trial.

BACKGROUND: The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has markedly increased over the last three decades due to newly found associations with human papillomavirus (HPV) infection. Primary radiotherapy (RT) is the treatment of choice for OPSCC at most centers, and over the last decade, the addition of concurrent chemotherapy has led to a significant improvement in survival, but at the cost of increased acute and late toxicity. Transoral robotic surgery (TORS) has emerged as a promising alternative treatment, with preliminary case series demonstrating encouraging oncologic, functional, and quality of life (QOL) outcomes. However, comparisons of TORS and RT in a non-randomized fashion are susceptible to bias. The goal of this randomized phase II study is to compare QOL, functional outcomes, toxicity profiles, and survival following primary RT (± chemotherapy) vs. TORS (± adjuvant [chemo] RT) in patients with OPSCC. METHODS/DESIGN: The target patient population comprises OPSCC patients who would be unlikely to require chemotherapy post-resection: Tumor stage T1-T2 with likely negative margins at surgery; Nodal stage N0-2, ≤3 cm in size, with no evidence of extranodal extension on imaging. Participants will be randomized in a 1:1 ratio between Arm 1 (RT ± chemotherapy) and Arm 2 (TORS ± adjuvant [chemo] RT). In Arm 1, patients with N0 disease will receive RT alone, whereas N1-2 patients will receive concurrent chemoradiation. In Arm 2, patients will undergo TORS along with selective neck dissections, which may be staged. Pathologic high-risk features will be used to determine the requirement for adjuvant radiotherapy +/- chemotherapy. The primary endpoint is QOL score using the M.D. Anderson Dysphagia Inventory (MDADI), with secondary endpoints including survival, toxicity, other QOL outcomes, and swallowing function. A sample of 68 patients is required. DISCUSSION: This study, if successful, will provide a much-needed randomized comparison of the conventional strategy of primary RT vs. the novel strategy of primary TORS. The trial is designed to provide a definitive QOL comparison between the two arms, and to inform the design of an eventual phase III trial for survival outcomes. TRIAL REGISTRATION: NCT01590355.

Pain and discomfort during flexible nasolaryngoscopy: a randomized, controlled trial assessing the efficacy of oral mouthwash and topical lidocaine.

PURPOSE: To test the hypothesis that using Listerine mouthwash prior to administration of topical nasal lidocaine will result in improved pain and comfort outcomes during flexible nasolaryngoscopy (FNL). DESIGN: Randomized, controlled trial. SUBJECTS: A total of 120 patients were randomized to receive a combination of either treatment or placebo mouthwash followed by treatment or placebo nasal spray prior to an FNL examination. OUTCOME MEASURES: Pain and discomfort using a 100 mm visual analogue scale. RESULTS: The use of lidocaine significantly reduced pain (p = .011) and discomfort (p = .008) compared to placebo nasal spray. Using Listerine prior to administration of lidocaine resulted in the largest reductions. Patients having an extended nasal examination reported more pain (p = .001) and discomfort (p = .03) levels while demonstrating a greater benefit of topical lidocaine compared to those undergoing a primary laryngeal examination (p < .001). DISCUSSION: Using Listerine prior to application of lidocaine nasal spray reduces the pain and discomfort of FNL. This effect was most clinically significant in patients undergoing an extended or full bilateral nasal examination.

Single-stage repair of subglottic stenosis using the radial forearm free flap as a vascularized carrier.

BACKGROUND: We present a case report of a patient with history of subglottic carcinoma who underwent chemoradiation and subsequently developed subglottic stenosis (SGS). METHODS AND RESULTS: She was treated with an anterior cricoid split maintained by septal cartilage wrapped in a partially deepithelialized radial forearm free flap (RFFF). To date, with a follow-up of 6 months, the patient has been fully decannulated and has not experienced airway collapse or any other complications. CONCLUSIONS: Upper airway reconstruction using a single-stage autogenous cartilage graft wrapped in a vascularized carrier is a real option for those patients with extensive SGS in the setting of an irradiated and devascularized tissue bed.