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.
Introduction The ancient Indian system of medicine, Ayurveda has a treatment for symptom complexes of a variety of disease. One such combination of Ayurvedic medications has potential for use in COVID 19 infection, hence a prospective study was conducted with this formulation as an add on, in COVID positive patients in a dedicated COVID Hospital. Objective To evaluate the additional benefit of an Ayurvedic regime in COVID +ve patients on the basis of rate of clinical improvement. Methodology The Ayurvedic formulation was administered as an add on to Standard of Care in patients with mild to moderate symptoms, in this prospective, open label, comparative study. Control group received Standard of Care only. Results Patients receiving Dasamoolkaduthrayam Kashaya & Guluchyadi Kwatham in tablet form in addition to the standard of care showed a faster recovery from dyspnoea with reduced ageusia. Patients on the treatment group could be discharged earlier than those from the control group. Conclusion Addition of Dasamoolkaduthrayam Kashaya & Guluchyadi Kwatham to Standard of Care appeared to accelerate recovery of patients hospitalized for COVID 19 infection, in terms of reduction of symptoms and duration of hospital stay.
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).
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.
Introduction This study aimed to demonstrate the safe and effective use of the Versius surgical system (CMR Surgical, Cambridge, UK) in robot‐assisted total laparoscopic hysterectomy. This surgical robot was developed iteratively with input from surgeons to improve surgical outcomes and end‐user experience. We report data from the gynecology cohort of an early clinical trial designed in broad alignment with IDEAL‐D (Idea, Development, Exploration, Assessment, Long‐term follow‐up – Devices) stage 2b (Exploration). Material and methods The study is registered in the Indian clinical trials register (CTRI/2019/02/017872). Adult women requiring total hysterectomy who provided informed consent and met the eligibility criteria underwent procedures at one of three hospitals in India. Five surgeons performed robot‐assisted total laparoscopic hysterectomies using the device from March 2019 to September 2020. The primary endpoint was rate of unplanned conversion to conventional laparoscopic or open surgery. Adverse events were adjudicated by an independent clinical events committee using endoscope video recordings and clinical notes. Results In total, 144 women underwent surgery (median age: 44 years [range: 28–78]; median body mass index 25.8 kg/m2 [range: 14.3–47.8]). The rate of unplanned conversion to conventional laparoscopy was 2/144 (1.4%); neither conversion was device related. No surgery was converted to open. In total, 13 adverse events occurred among seven (4.9%) patients, comprising seven serious adverse events and six adverse events. One serious adverse event was deemed device‐related. Two patients were readmitted to hospital within 30 days; both made a full recovery. No patients died within 90 days of surgery. Conclusions The device provides a safe and effective option for total laparoscopic hysterectomy; these findings support its continued implementation in larger patient cohorts and expansion in other major minimal access indications.
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