Patient Experience of Head and Neck Surgery With Free Flap Reconstruction.

Importance: Major head and neck surgery with microvascular free tissue transfer reconstruction is complex, with considerable risk of morbidity. Little is known about patients' experiences, including decision-making prior to, and regret following, free flap surgery. Objective: To characterize patient experiences and decision regret of patients undergoing head and neck reconstructive free flap surgery. Design, Setting, and Participants: This mixed-methods cohort study comprising semistructured interviews was conducted June to August 2021 at a single tertiary academic cancer center. Participants underwent head and neck reconstructive surgery with microvascular free tissue transfer (flap) more than 3 months before recruitment (range, 3 months to 4 years). Interview transcripts were qualitatively analyzed for themes. Participants also completed a Decision Regret Scale questionnaire. Exposure: Microvascular free flap surgery for head and neck reconstruction. Main Outcomes and Measures: Thematic analysis of interviews, decision regret score. Results: Seventeen participants were interviewed. Median (IQR) age was 61 (52-70) years. Overall, 7 participants were women (49%), and 10 of 17 were men (59%). The most common free flap was fibula (8/17, 47%). Three major themes with 9 subthemes were identified: theme 1 was the tremendous effect of preoperative counseling on surgical decision-making and satisfaction, with subthemes including (1) importance of clinical care team counseling on decision to have surgery; (2) emotional context colors preoperative understanding and retention of information; (3) expectation-setting affects satisfaction with preoperative counseling; and (4) desire for diversified delivery of preoperative information. Theme 2 was coexisting and often conflicting priorities, including (1) desire to survive above all else, and (2) desire for quality of life. Theme 3 was perception of surgery as momentous and distressing, including (1) surgery as a traumatic event; (2) centrality of mental health, emotional resolve, and gratitude to enduring surgery and recovery; and (3) sense of accomplishment in recovery. On the Decision Regret Scale, most participants had no regret (n = 8, 47%) or mild regret (n = 5, 29%); 4 had moderate-to-severe regret (24%). Conclusions and Relevance: In this mixed-methods cohort study, patient experiences surrounding major head and neck reconstructive free flap surgery were described. Opportunities to improve support for this complex and vulnerable population, and to mitigate decision regret, were identified.

Development of a head and neck lymphoedema specific quality of life tool: The Comprehensive Assessment of Lymphoedema Impact in the Head and Neck.

PURPOSE: To develop a head and neck lymphoedema (HNL) specific quality of life (QoL) instrument to assess physical, functional, and social/emotional impacts of HNL. METHODS: Instrument candidate items were reviewed by patients with HNL and clinicians and rated for importance, clarity, and invasiveness. The Content Validity Ratio was applied for item reduction. Three-step cognitive interviews were conducted with HNL patients to validate the items, survey format, and instructions. RESULTS: Initially, 130 candidate questions were developed. Following item reduction, 52 items progressed to three-step cognitive interviews. Following cognitive interviews, the Comprehensive Assessment of Lymphoedema Impact in Head and Neck (CALI-HaN) included 33 items; 1 global, 10 physical, 7 functional, and 15 emotional. CONCLUSIONS: Physical, functional, and socioemotional effects need to be considered when measuring QoL in patients with HNL. This study describes initial development of the CALI-HaN, an instrument that shows promise for clinical and research applications following future validation.

Use of the G8 Geriatric Screening Tool in Surgical Head and Neck Cancer Patients Requiring Rehabilitation: A Multisite Investigation.

OBJECTIVES: The G8 is a well-validated screening test for older cancer patients. The current study was undertaken to determine whether the G8 is predictive of short-term post-operative outcomes after head and neck cancer (HNC) surgery. METHODS: Consecutive patients aged 65 years or more and referred for a preoperative assessment by a speech-language pathologist were consecutively screened by clinicians at 2 academic medical centers using the G8. The G8 was used to screen for vulnerability prior to surgery. Patients were deemed vulnerable if they had a total G8 score ≤14 according to published guidelines. Data were also collected on demographic characteristics, tumor staging, post-operative course, and tracheostomy and feeding tube (FT) status. RESULTS: Ninety patients were consecutively screened during the study period. Using the G8, 64% of the patients were deemed vulnerable. Vulnerable patients differed significantly from non-vulnerable patients with regard to age, health, tumor stage, and baseline dysphagia, and underwent more extensive surgery. Postoperatively, vulnerable patients had a significantly longer hospital length of stay (LOS; 10.17 vs 5.50 days, respectively, P < .001), were less likely to discharge home (76% vs 94%, P = .044), and were more likely to be FT dependent for over a month (54% vs 21%, P = .006) compared to non-vulnerable patients. In regression models, controlling for T-stage and surgical variables, the G8 independently predicted 2 post-operative outcomes of interest, namely LOS and FT dependency. CONCLUSIONS: The G8 may be a useful screening tool for identifying older adults at risk of a protracted postoperative medical course after HNC surgery. Future research should aim to identify the optimal screening protocol and how this information can be incorporated into clinical pathways to enhance the post-operative outcomes of older HNC patients.

Head and neck lymphedema and quality of life: the patient perspective.

PURPOSE: Head and neck lymphedema (HNL) is common after head and neck cancer (HNC). This study aimed to explore quality of life (QoL) in patients with HNL to guide the development of a patient-reported QoL measure. METHODS: We conducted semi-structured interviews with 22 HNC survivors with HNL. Interviews explored participants' experiences of living with HNL. Analysis of interview transcripts drew on qualitative content analysis to ensure themes were grounded in patient experience. RESULTS: Two main themes were established: "I want to live my life" and "It was like things were short-circuited." These themes encompassed the substantial disruption patients attributed to the HNL and their desire to normalize life. CONCLUSIONS: Understanding the impact of HNL on individual patients may be critical to optimizing treatment strategies to improve the physical burden of HNL and QoL. This study provides the framework for developing a patient-reported HNL QoL measure. IMPLICATIONS FOR CANCER SURVIVORS: The development of an HNL-specific QoL measure, grounded in the patient perspective, may provide cancer care teams with a tool to better understand HNL's impact on each patient to tailor patient-centered care and optimize QoL outcomes.

Expert Consensus Statement: Management of Dysphagia in Head and Neck Cancer Patients.

OBJECTIVE: To develop an expert consensus statement (ECS) on the management of dysphagia in head and neck cancer (HNC) patients to address controversies and offer opportunities for quality improvement. Dysphagia in HNC was defined as swallowing impairment in patients with cancers of the nasal cavity, paranasal sinuses, nasopharynx, oral cavity, oropharynx, larynx, or hypopharynx. METHODS: Development group members with expertise in dysphagia followed established guidelines for developing ECS. A professional search strategist systematically reviewed the literature, and the best available evidence was used to compose consensus statements targeted at providers managing dysphagia in adult HNC populations. The development group prioritized topics where there was significant practice variation and topics that would improve the quality of HNC patient care if consensus were possible. RESULTS: The development group identified 60 candidate consensus statements, based on 75 initial proposed topics and questions, that focused on addressing the following high yield topics: (1) risk factors, (2) screening, (3) evaluation, (4) prevention, (5) interventions, and (6) surveillance. After 2 iterations of the Delphi survey and the removal of duplicative statements, 48 statements met the standardized definition for consensus; 12 statements were designated as no consensus. CONCLUSION: Expert consensus was achieved for 48 statements pertaining to risk factors, screening, evaluation, prevention, intervention, and surveillance for dysphagia in HNC patients. Clinicians can use these statements to improve quality of care, inform policy and protocols, and appreciate areas where there is no consensus. Future research, ideally randomized controlled trials, is warranted to address additional controversies related to dysphagia in HNC patients.

Assessment of Measures of Head and Neck Lymphedema Following Head and Neck Cancer Treatment: A Systematic Review.

Purpose: Head and neck lymphedema is a common condition following head and neck cancer (HNC) treatment, with substantial functional morbidity. This systematic review aimed to (1) identify tools used to assess head and neck lymphedema in HNC patients and (2) determine their validity and reliability. Methods: Electronic and hand searches of Prospero, MEDLINE, Cochrane Library, and Embase were searched from their inception until April 2021, and hand searches were independently screened by two reviewers. Studies were included if they were available in English and measured lymphedema in adult HNC patients (aged ≥18 years). Data including psychometric characteristics were extracted and synthesized narratively, with the Quality Assessment of Diagnostic Accuracy Studies-2 and the COnsensus-based Standards for the selection of health Measurement INstruments checklists used to assess risk of bias. Results: Thirty-three studies, reporting 38 assessment tools, were included. Assessments included clinician rating scales, symptom inventories, size measures, measures of internal edema, radiographic and ultrasonographic measures, and quality-of-life measures. Of the 38 measures cited, only 11 had any degree of validation and reliability testing. Risk of bias varied among the different assessment tools. Conclusion: While many tools are used in the assessment of head and neck lymphedema, the majority of these tools lack validation and reliability data. Only one tool, the Head and Neck Lymphedema and Fibrosis Symptom Inventory, met criteria for strong quality assessment. Further efforts to establish a core set of metrics for this complex condition are warranted.

Head and Neck Virtual Coach: A Randomized Control Trial of Mobile Health as an Adjunct to Swallowing Therapy During Head and Neck Radiation.

Dysphagia is a common consequence of head and neck radiation and may be mitigated by performance of swallowing exercises during radiation treatment. Given historically poor adherence to such exercise protocols, we created a mobile health application, HNC Virtual Coach as an adjunct to standard clinical care. This randomized control trial investigated the impact of HNC Virtual Coach on adherence as well as swallowing outcomes by comparing those using the mobile app to those receiving only standard clinical care and paper logs. Both treatment groups were provided with the same exercise protocol as well as the same baseline educational information. Outcome measures included adherence rates, physiologic measures obtained during a Modified Barium Swallow Study (PAS, MBS-ImP, DIGEST), patient-reported outcomes (MDADI), diet levels (FOIS, PSS-HN), and quality of information received (INFO-25). Patients using the HNC Virtual Coach tended to have better adherence to treatment recommendations during radiation therapy. Increased adherence was associated with better patient-reported quality of life, but not physiologic function 2-3 months following completion of radiation. Results suggest that a mobile health application may provide benefit for some patients undergoing head and neck radiation.

Practice patterns in transoral robotic surgery: results of an American head and neck society survey.

To understand perioperative practices for transoral robotic surgery (TORS) among academic medical centers. An electronic cross-sectional survey was distributed to fellows and program directors participating in 49 American Head and Neck Society fellowships. Operative decisions, medical and swallowing management, and disposition planning were assessed. Thirty-eight responses were collected (77.6%). Twenty-three centers (60.5%) performed > 25 cases annually with the remainder performing fewer. The da Vinci Si was the most commonly used platform (n = 28, 73.7%). A majority of institutions advocated tailored resection to adequate margins (n = 27, 71.1%) over fixed subunit-based resection (n = 11, 28.9%). Most surgeons (n = 29, 76.3%) performed neck dissection concurrent with TORS, and 89.5% (n = 34) routinely ligated external carotid artery branches. A minority of institutions (n = 17, 45.9%) endorsed a standardized TORS care pathway. Antibiotic choices and duration varied, the most common choice being ampicillin/sulbactam (n = 21, 55.3%), and the most common duration being 24 h or less (n = 22, 57.9%). Multimodal analgesia was used at 36 centers (94.7%), steroids at 31 centers (81.6%), and pharmacologic venous thromboembolic prophylaxis at 29 centers (76.3%). Nasogastric feeding tubes were placed during surgery at 20 institutions (54.1%). Speech-language pathologists routinely performed postoperative swallow evaluations at 29 (78.4%) sites. Practice patterns are variable among institutions performing TORS. While certain surgical and postoperative practices were quite common, many institutions reported no standard TORS care pathway. Further understanding of the impact of individual practices on outcomes is necessary to develop evidence-based perioperative protocols for TORS.

Transoral Robotic Surgery for Recurrent Tumors of the Upper Aerodigestive Tract (RECUT): An International Cohort Study.

BACKGROUND: Transoral robotic surgery (TORS) is an emerging minimally invasive surgical treatment for residual, recurrent, and new primary head and neck cancers in previously irradiated fields, with limited evidence for its oncological effectiveness. METHODS: A retrospective observational cohort study of consecutive cases performed in 16 high-volume international centers before August 2018 was conducted (registered at clinicaltrials.gov [NCT04673929] as the RECUT study). Overall survival (OS), disease-free survival, disease-specific survivals (DSS), and local control (LC) were calculated using Kaplan-Meier estimates, with subgroups compared using log-rank tests and Cox proportional hazards modeling for multivariable analysis. Maximally selected rank statistics determined the cut point for closest surgical resection margin based on LC. RESULTS: Data for 278 eligible patients were analyzed, with median follow-up of 38.5 months. Two-year and 5-year outcomes were 69.0% and 62.2% for LC, 71.8% and 49.8% for OS, 47.2% and 35.7% for disease-free survival, and 78.7% and 59.1% for disease-specific survivals. The most discriminating margin cut point was 1.0 mm; the 2-year LC was 80.9% above and 54.2% below or equal to 1.0 mm. Increasing age, current smoking, primary tumor classification, and narrow surgical margins (≤1.0 mm) were statistically significantly associated with lower OS. Hemorrhage with return to theater was seen in 8.1% (n = 22 of 272), and 30-day mortality was 1.8% (n = 5 of 272). At 1 year, 10.8% (n = 21 of 195) used tracheostomies, 33.8% (n = 66 of 195) used gastrostomies, and 66.3% (n = 53 of 80) had maintained or improved normalcy of diet scores. CONCLUSIONS: Data from international centers show TORS to treat head and neck cancers in previously irradiated fields yields favorable outcomes for LC and survival. Where feasible, TORS should be considered the preferred surgical treatment in the salvage setting.

Adaptation and Validation of the Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing: DIGEST-FEES.

Purpose While flexible endoscopic evaluation of swallowing (FEES) is a common clinical procedure used in the head and neck cancer (HNC) population, extant outcome measures for FEES such as bolus-level penetration-aspiration and residue scores are not well suited as global patient-level endpoint measures of dysphagia severity in cooperative group trials or clinical outcomes research. The Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) was initially developed and validated for use during videofluoroscopic evaluations as a way to grade safety, efficiency, and overall pharyngeal swallowing impairment. The purpose of this study was to adapt and validate DIGEST for use with FEES. Method A modified Delphi exercise was conducted for content validation, expert consensus, adaptation, and operationalization of DIGEST-FEES. Three blinded, expert raters then evaluated 100 de-identified post-HNC treatment FEES examinations. Intra- and interrater reliability were tested with quadratic weighted kappa. Criterion validity against the MD Anderson Dysphagia Inventory, Functional Oral Intake Scale, Secretion Severity Scale, and Yale Residue Rating Scale was assessed with Spearman correlation coefficients. Results Interrater reliability was almost perfect for overall DIGEST-FEES grade (κw = 0.83) and safety grade (κw = 0.86) and substantial for efficiency grade (κw = 0.74). Intrarater reliability was excellent for all raters (0.9-0.91). Overall DIGEST-FEES grade correlated with MD Anderson Dysphagia Inventory (r = -.43, p < .0001), Functional Oral Intake Scale (r = -.43, p < .0001), Secretion Severity Scale (r = .47, p < .0001), Yale Vallecular Residue (r = .73, p < .0001), and Yale Pyriform Sinus Residue (r = .65, p < .0001). Conclusion DIGEST-FEES is a valid and reliable scale to describe the severity of pharyngeal dysphagia in patients with HNC. Supplemental Material https://doi.org/10.23641/asha.14642787.

Development and reliability of the revised Patterson Edema Scale.

OBJECTIVE: The Patterson Edema scale was developed in 2007 to address the lack of a reliable, sensitive scale to measure laryngeal and pharyngeal oedema in patients with head and neck cancer. The objective of this study was to revise the existing Patterson scale to improve its reliability and utility. DESIGN: Prospective investigation. SETTING: Academic medical center. PARTICIPANTS: Speech-Language Pathologists, Otolaryngologists, and Radiation Oncologists. MAIN OUTCOME MEASURES: Ratings using the Revised Patterson Edema Scale. METHODS: A consensus group reviewed existing literature regarding the performance of the original Patterson scale and revised the existing scale in regard to items to be included and descriptors for each severity level. The scale was then utilised by 18 speech language pathologists from the US and UK with >2 years-experience working with dysphagia and dysphonia with endoscopy. Each SLP rated a total of eight parameters (epiglottis, vallecula, pharyngoepiglottic folds, aryepiglottic folds, arytenoids, false vocal folds, true vocal folds and pyriform sinuses) using the Revised Patterson Edema Scale. Feedback was solicited from raters regarding areas where clarity was lacking for further scale revision. Scale revisions were completed and additional ratings were completed by otolaryngologists, radiation oncologists and less experienced SLP providers to establish reliability across disciplines. Quadratic weighted Kappa values were obtained to establish interrater reliability. RESULTS: Feedback received from raters included suggestions for clarification of how to rate unilateral oedema, use of a standard task battery to visualise and rate structures consistently, and clarification of true vocal fold oedema rating parameters. Overall interrater reliability was established using quadratic weighted Kappa with good agreement noted for the epiglottis, vallecula, arytenoids and false vocal folds; moderate agreement noted for aryepiglottic folds, pharyngoepiglottic folds and pyriform sinuses; and fair agreement noted for true vocal folds. CONCLUSIONS: The Revised Patterson Edema Scale demonstrates moderate-substantial interrater reliability for most parameters across multiple disciplines and experience levels, with the exception of the true vocal folds where agreement was fair. We believe the Revised Patterson Oedema Scale provides a reliable tool for clinicians and researchers to rate oedema in the supraglottic larynx and pharynx following treatment for head and neck cancer.

Patient Reported Outcomes and Objective Swallowing Assessments in a Multidisciplinary Dysphagia Clinic.

OBJECTIVES/HYPOTHESIS: Dysphagia encompasses a complex compilation of symptoms which often differ from findings of objective swallowing evaluations. The purpose of this investigation was to compare the results of subjective dysphagia measures to objective measures of swallowing in patients evaluated in a multidisciplinary dysphagia clinic. STUDY DESIGN: Prospective cohort study. METHODS: The study cohort included all patients evaluated in the multidisciplinary dysphagia clinic over 24 months. Participants were evaluated by a multidisciplinary team including a laryngologist, gastroenterologist, and speech-language pathologist. Evaluation included a videofluoroscopic swallowing study (VFSS), fiberoptic endoscopic evaluation of swallowing (FEES), and transnasal esophagoscopy (TNE). Data collected included diet (FOIS), Eating Assessment Tool (EAT-10) score, Reflux symptom index (RSI) score, and the findings of the VFSS exam. RESULTS: A total of 75 patients were included in the analysis. The average EAT-10 score was 16.3 ± 2.1, RSI was 21.4 ± 0.6, and FOIS score was 6.0 ± 1.33. VFSS revealed impairments in the oral phase in 40% of the cohort, pharyngeal in 59%, and esophageal in 49%. Abnormalities were noted in one phase for 32%, in 2 phases in 32%, and three phases in 18%. Patients with abnormal pharyngeal findings on VFSS had significantly higher EAT-10 scores (P = .04). Patients with abnormal oral findings on VFSS were noted to have significantly lower FOIS scores (P = .03). CONCLUSIONS: Data presented here demonstrate a relationship between patient reported symptoms and objective VFSS findings in a cohort of patients referred for multidisciplinary swallowing assessment suggesting such surveys are helpful screening tools but inadequate to fully characterize swallowing impairment. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:1088-1094, 2021.

Swallowing and Communication Management of Tracheostomy and Laryngectomy in the Context of COVID-19: A Review.

IMPORTANCE: The care of patients with a surgically modified airway, such as tracheostomy or laryngectomy, represents a challenge for speech-language pathologists (SLPs) in the context of the coronavirus disease 2019 (COVID-19) pandemic. The objective was to review available publications and practice guidelines on management of tracheostomy and laryngectomy in the context of COVID-19. This study performed a review and synthesis of information available in the PubMed database and from national SLP organizations across 6 countries. OBSERVATIONS: From the search, 22 publications on tracheostomy and 3 referring to laryngectomy were identified. After analysis of titles and abstracts followed by full-text review, 4 publications were identified as presenting guidelines for specific approaches to tracheostomy and were selected; all 3 publications on laryngectomy were selected. The main guidelines on tracheostomy described considerations during management (eg, cuff manipulation, suctioning, valve placement) owing to the increased risk of aerosol generation and transmission during swallowing and communication interventions in this population. Regarding laryngectomy, the guidelines focused on the care and protection of both the professional and the patient, offering recommendations on the management of adverse events and leakage of the tracheoesophageal prosthesis. CONCLUSIONS AND RELEVANCE: Frequent guideline updates for SLPs are necessary to inform best practice and ensure patient and health care worker protection and safety while providing high-quality care and rehabilitation.

Managing head and neck cancer patients with tracheostomy or laryngectomy during the COVID-19 pandemic.

Head and neck cancer patients with tracheostomies and laryngectomies, as well as their healthcare providers, face unique challenges in the context of the current COVID-19 pandemic. This document consolidates best available evidence to date and presents recommendations to minimize the risks of aerosolization and SARS-CoV-2 exposures in both the inpatient and outpatient settings. The cornerstones of these recommendations include the use of closed-circuit ventilation whenever possible, cuffed tracheostomy tubes, judicious use of heat moisture exchange units, appropriate personal protective equipment for providers and patients, meticulous hand hygiene, and minimal manipulation of tracheostomy tubes.

Management of dysphagia in the patient with head and neck cancer during COVID-19 pandemic: Practical strategy.

The global pandemic of 2019 novel coronavirus disease (COVID-19) has tremendously altered routine medical service provision and imposed unprecedented challenges to the health care system. This impacts patients with dysphagia complications caused by head and neck cancers. As this pandemic of COVID-19 may last longer than severe acute respiratory syndrome (SARS) in 2003, a practical workflow for managing dysphagia is crucial to ensure a safe and efficient practice to patients and health care personnel. This document provides clinical practice guidelines based on available evidence to date to balance the risks of SARS-CoV-2 exposure with the risks associated with dysphagia. Critical considerations include reserving instrumental assessments for urgent cases only, optimizing the noninstrumental swallowing evaluation, appropriate use of personal protective equipment (PPE), and use of telehealth when appropriate. Despite significant limitations in clinical service provision during the pandemic of COVID-19, a safe and reasonable dysphagia care pathway can still be implemented with modifications of setup and application of newer technologies.

Effectiveness of a Home-based Head and Neck Lymphedema Management Program: A Pilot Study.

OBJECTIVE: This study aimed to compare outcomes in patients with head and neck lymphedema receiving either a home-based lymphedema treatment program or a hybrid approach including both home-based treatment and regular clinical visits. METHODS: Outcomes were assessed in patients receiving head and neck lymphedema rehabilitation. Baseline measures of neck, submental, and facial edema were obtained and repeated following treatment. A home program was recommended for all patients, and those receiving hybrid care received the same recommendations as well as a visit with the lymphedema therapist for additional treatment. Their outcomes were compared using standard statistical analysis. RESULTS: Fifty consecutive individuals were included, 25 in each group. Adherence to at least 50% of recommended treatment was reported in 68% of those receiving home-based treatment and 84% of those receiving hybrid care. Significant improvement was demonstrated for 66% of patients. There was no statistically significant difference between treatment groups with regard to clinically significant improvement (P = .15). Patients receiving hybrid therapy demonstrated treatment advantages regarding facial edema (P = .037). Adherence to treatment was associated with clinical improvement (P = .047). CONCLUSIONS: Comparable benefits were observed regardless of whether patients had a home-based or hybrid lymphedema treatment approach. These data suggest a home-based treatment approach may be appropriate for patients unable to participate in clinical sessions. However, for patients with significant facial edema, a hybrid approach may be preferable. Adherence was associated with better outcomes. Given these findings, future investigations should consider strategies to improve adherence to optimize the outcomes lymphedema treatment. LEVEL OF EVIDENCE: 3b Laryngoscope, 2020.

Patient advocacy in head and neck cancer: Realities, challenges and the role of the multi-disciplinary team.

This paper explores the concept of advocacy in head and neck cancer. We define inherent challenges in the development and success of advocacy within this context and offer ways to embed it within clinical practice. We outline what advocacy is, ways in which it may benefit people with head and neck cancer and the engagement required from healthcare professionals to facilitate advocacy to improve outcomes.

A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials.

IMPORTANCE: Transoral endoscopic head and neck surgery now plays an important role in the multidisciplinary management of oropharyngeal carcinoma. Previous generations of robotic surgical systems used a multiport system with a rigid stereo-endoscope and 2 wristed instruments that facilitated transoral robotic surgery. OBJECTIVE: To evaluate a new single-port robotic surgical system in head and neck surgery prospectively through concurrent nonrandomized clinical trials. DESIGN, SETTING, AND PARTICIPANTS: Two prospective clinical trials were conducted from December 16, 2016, to December 26, 2017, to assess the safety, feasibility, and performance of a flexible single-port robotic surgical system in 4 institutions, including 3 in the United States and 1 in Hong Kong. A total of 47 patients with tumors of the oropharynx were enrolled and underwent surgery. All patients were classified as having American Society of Anesthesiologists class I to III status and Eastern Cooperative Oncology Group status 0 to 1. An initial cohort of 7 patients underwent staging and endoscopic procedures for benign disease. The remaining 40 patients all had malignant tumors of the oropharynx. MAIN OUTCOMES AND MEASURES: Safety was measured by the incidence of device-related serious adverse events. Feasibility and performance were measured by the conversion rate from the use of the single-port robotic surgical system to either open surgery or the use of any other transoral technology required to complete the planned procedure. Secondary end points of swallowing function and surgical margins were also measured. RESULTS: All 47 patients (8 women and 39 men; mean [SD] age, 61 [8] years) safely underwent transoral resection with the single-port robotic surgical system without conversion to open surgery, laser surgery, or multiport robotic surgery. There were no intraoperative complications or device-related serious adverse events. Mean (SD) estimated intraoperative blood loss per procedure was 15.4 (23.9) mL; no patients received a transfusion. Two patients underwent a planned tracheotomy owing to medical comorbidity (previous chemoradiotherapy; obesity and severe sleep apnea). Two patients (4%) had grade III or IV postoperative hemorrhage, requiring a return to the operating room; however, both patients had medical comorbidities requiring the use of antithrombotic medication. The incidence of positive margins for patients with oropharyngeal malignancy was 3% (1 of 40). Within 30 days, 45 patients (96%) were eating by mouth and without the need for a percutaneous endoscopic gastrostomy tube. CONCLUSIONS AND RELEVANCE: This study describes the results of phase 2 clinical testing of a next-generation, robotic surgical system using a single-port architecture. The use of the device appears to be feasible, safe, and effective for transoral robotic surgery of oropharyngeal tumors. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT03010813 and NCT03049280.