Diffusion and adoption of the surgical robot in urology.

Over the last two decades, robotic surgery has become a mainstay in hospital systems around the world. Leading this charge has been Intuitive Surgical Inc.'s da Vinci robotic system (Sunnyvale, CA, USA). Through its innovative technology and unique revenue model, Intuitive has installed 4,986 robotic surgical systems worldwide in the last two decades. The rapid rate of adoption and diffusion of the surgical robot has been propelled by many important industry-specific factors. In this review, we propose a model that explains the successful adoption of robotic surgery due to its three core groups: the surgeon, the hospital administrator, and the patient.

Adverse event reporting in head and neck transoral robotic surgery: a MAUDE database study.

Transoral robotic surgery (TORS) using the da Vinci Surgical system was approved by the US Food and Drug Administration in 2009. Currently, most available safety information on TORS procedures describes adverse events occurring in the context of clinical trials or series at high-volume academic centers. The goal of this study was to catalog reported adverse events associated with the da Vinci device in head and neck procedures by querying an FDA database. A search was performed on the MAUDE database inspecting for TORS safety incident reports generated from January 2009 through May 2020 using key words "da Vinci" and "Intuitive Surgical". A total of 3312 medical device records were produced. Of these 36 head and neck adverse events, reports were identified through manual screening of the data by the authors. Death was found to be the most common adverse event reported overall, manifesting in 44% of all reported incidents. The most frequent source of mortality was found to be hemorrhaging in the perioperative period rather than incidents of device malfunction or structural damage from surgery. This was found to be similar to the results of other published series for transoral ablative surgery. This study suggests that the small number of reported adverse events related to TORS with the da Vinci system seems to mirror what would be expected from the same procedures using other methods for transoral surgery.

Current Novel Advances in Bronchoscopy.

Screening for lung cancer has changed substantially in the past decade since The National Lung Screening Trial. The resultant increased discovery of incidental pulmonary nodules has led to a growth in the number of lesions requiring tissue diagnosis. Bronchoscopy is one main modality used to sample lesions, but peripheral lesions remain challenging for bronchoscopic biopsy. Alternatives have included transthoracic biopsy or operative biopsy, which are more invasive and have a higher morbidity than bronchoscopy. In hopes of developing less invasive diagnostic techniques, technologies have come to assist the bronchoscopist in reaching the outer edges of the lung. Navigational bronchoscopy is able to virtually map the lung and direct the biopsy needle where the scope cannot reach. Robotic bronchoscopy platforms have been developed to provide stability and smaller optics to drive deeper into the bronchial tree. While these new systems have not yet proven better outcomes, they may reduce the need for invasive procedures and be valuable armamentarium in diagnosing and treating lung nodules, especially in the periphery.

Sponsoring surgeons: An investigation on the influence of the da Vinci robot.

INTRODUCTION: The integrity of the medical literature about robotic surgery remains unclear despite wide-spread adoption. We sought to determine if payment from Intuitive Surgical Incorporated (ISI) affected quality of the research produced by surgeons. METHODS: Publicly available financial data from the CMS website regarding the top-20 earners from ISI for 2015 was gathered. Studies conducted by these surgeons were identified using PubMed. Inclusion criteria consisted of publications about the da Vinci® robot on patient outcomes. The primary outcome of our study was if the study conclusion was positive/equivocal/negative towards the robot. Secondary outcomes included authorship, sponsorship, study controls, and disclosure. RESULTS: The top earners received $3,296,844 in 2015, with a median of $141,959. Sub-specialties included general surgery (55%), colorectal (20%), thoracic (15%), and obstetrics/gynecology (10%). Of the 37 studies, there was 1 RCT, with observational studies comprising the rest. The majority of the studies (n = 16, 43%) had no control population, with 11 (30%) comparing to same institution/surgeon, Though ISI sponsored only 6 (16%) studies, all with positive conclusions, 27 (73%) studies had positive conclusions for robot use, 9 (24%) equivocal, and only 1 (3%) negative. Overall, 13 earners had lead authorship and 11 senior. CONCLUSION: This initial pilot study highlights a potential bias as current literature published by benefactors demonstrates low quality and highly positive conclusions towards approval of the robot. This substantiates the need for a large, systematic review of the potential influence of sponsoring surgeons on medical literature.

Safety and feasibility of reduced-port robotic distal gastrectomy for gastric cancer: a phase I/II clinical trial.

INTRODUCTION: Theoretically, reducing the number of ports required in minimally invasive surgery for gastric cancer would further minimize trauma associated therewith. Advances in single-site surgery have afforded surgeons the ability to perform reduced-port distal gastrectomy via a robotic approach using the Single-Site™ system, eliminating restrictions on the movement of surgical instruments. METHODS: This phase I/II study was designed as a single-arm prospective trial of reduced-port robotic distal gastrectomy (RRDG) by a single surgeon (NCT02347956). From January to October 2015, 40 individuals scheduled to undergo robotic surgery for early gastric cancer were asked to participate in the trial. Nineteen were enrolled and underwent RRDG. The primary endpoints were 30-day morbidity and mortality. RESULTS: No intraoperative event requiring conversion to laparoscopic or open surgery occurred, and no major complication was observed following RRDG (0.0% [80% CI (0.0-11.4%)]). Medians of operation time, blood loss, the number of retrieved lymph nodes, days until gas passing, and hospital stay were 190 min, 20 mL, 48, 3, and 5 days, respectively. CONCLUSIONS: Deemed safe and feasible through the present trial, RRDG could be a valid alternative to conventional robot distal gastrectomy for managing early gastric cancer. Our reduced-port robotic surgery using the Single-Site system and a third robotic arm could potentially be applicable as a highly advanced, minimally invasive surgery for other solid organ diseases.