Objective The aim of this study was to provide an interim safety analysis of the first 30 surgical procedures performed using the Versius Surgical System. Background Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is currently undergoing a first-in-human prospective clinical trial to confirm the safety and effectiveness of the device when performing minimal access surgery (MAS). Methods Procedures were performed using Versius by a lead surgeon supported by an operating room (OR) team. Male or female patients aged between 18 and 65 years old and requiring elective minor or intermediate gynaecological or general surgical procedures were enrolled. The primary endpoint was the rate of unplanned conversion of procedures to other MAS or open surgery. Results The procedures included nine cholecystectomies, six robot-assisted total laparoscopic hysterectomies, four appendectomies, five diagnostic laparoscopy cases, two oophorectomies, two fallopian tube recanalisation procedures, an ovarian cystectomy and a salpingo-oophorectomy procedure. All procedures were completed successfully without the need for conversion to MAS or open surgery. No patient returned to the OR within 24 h of surgery and readmittance rate at 30 and 90 days post-surgery was 1/30 (3.3%) and 2/30 (6.7%), respectively. Conclusions This first-in-human interim safety analysis demonstrates that the Versius Surgical System is safe and can be used to successfully perform minor or intermediate gynaecological and general surgery procedures. The cases presented here provide evidence that the Versius clinical trial can continue to extend recruitment and begin to include major procedures, in alignment with the IDEAL-D Framework Stage 2b: Exploration.

The aim of this study was to demonstrate the ability of the Versius Surgical System to successfully and safely complete cholecystectomy. Background: The system has been developed in-line with surgeon feedback to overcome limitations of conventional laparoscopy to enhance surgeon experience and patient outcomes. Here we present results from the cholecystectomy cohort from a completed early clinical trial, which was designed to broadly align with Stage 2b of the Idea, Development, Exploration, Assessment, Long-term follow-up framework for surgical innovation. Methods: Procedures were performed between March 2019 and September 2020 by surgical teams consisting of a lead surgeon and operating room (OR) assistants. Male or female patients aged 18 years and over and requiring cholecystectomy were enrolled. The primary endpoint was the rate of unplanned conversion from robot-assisted surgery to conventional laparoscopic or open surgery. Adverse events (AEs) and serious AEs were adjudicated by video review of the surgery and patient study reports by an independent Clinical Expert Committee. Results: Overall, 134/143 (93.7%) cholecystectomies were successfully completed using the device. Of the 9 (6.3%) conversions to another surgical modality, 7 were deemed to be related to the device. A total of 6 serious AEs and 3 AEs occurred in 8 patients (5.6%), resulting in 4 (2.8%) readmissions to hospital within 30 days of surgery and 1 death. Conclusions: This study demonstrates cholecystectomy performed using the device is as safe and effective as conventional laparoscopy and supports the implementation of the device on a wider scale, pending instrument modifications, in alignment with Idea, Development, Exploration, Assessment, Long-term follow-up Stage 3 (Assessment).

BackgroundComplicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.MethodsIn this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196).ResultsIn the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.ConclusionsTigecycline was generally safe and effective in the treatment of cSSSIs.Trial registrationClinicalTrials.gov NCT00368537

Supplemental features for educational videos; 3) Differences between high and low quality surgical videos; 4) Barriers to viewing video prior to surgery. Individual qualitative interviews were transcribed verbatim, coded and analyzed by two independent reviewers using NVivo12 Pro. RESULTS: Eighteen residents participated in qualitative interviews with 12 (67%) senior level residents (post-graduate year 3 or 4) and 6 (33%) junior level residents (post-graduate year 1 or 2). All residents had completed 10 or less vaginal hysterectomies at the time of the interviews. Gynecology residents characterized high-yield vaginal hysterectomy videos as short, accessible surgical videos available on mobile applications (Figure 1). Residents desired videos that highlight and provide insight into challenging techniques: anterior peritoneal entry, uterosacral pedicles and vaginal cuff closure. With regards to desired supplemental material, senior level residents identified intraoperative complications and troubleshooting as important whereas junior level residents identified instrumentation and anatomy review. Trainees described high quality videos as those with adequate visualization, graphics to demarcate anatomy overlaid on the dissection, review of challenging techniques and descriptive audio. Low quality videos were described as long duration, poor visualization and inadequate audio explanation. Resident awareness and video accessibility were common barriers that prevented residents from viewing vaginal hysterectomy videos prior to surgery. The importance of an accessible mobile application with short, descriptive videos were congruent across all resident experience levels. CONCLUSION: Gynecology residents desire short, app-based vaginal hysterectomy videos that are easily accessible. Understanding residents' perspective can aid educators to create videos directed toward resident learning preferences.

Multiple synchronous malignancies are rarer than metachronous ones. Primary synchronous breast and renal cancer is even rare. Such a case requires strict exclusion of possible metastasis to either site and to confirm the primary nature of each malignancy for better outcome of management and survival benefit. Multiple primary synchronous malignancies may be due to shared genetic mutations if any common carcinogenic factor cannot be found. The role of estrogens in cases in which human renal carcinoma is associated with other primary tumours involving steroid-hormone target tissues, is tentative and can only be hypothesised due to paucity of such data in literature. One should consider the possibility of concomitant dual or multiple primary tumours in a patient presented with mass lesions at various sites, especially if one of the sites is the kidney. We present a case report of a patient with synchronous primary breast and renal cancer.