An Early Prospective Clinical Study to Evaluate the Safety and Performance of the Versius Surgical System in Robot-Assisted Cholecystectomy.

OBJECTIVE: 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).

Early evaluation of a next-generation surgical system in robot-assisted total laparoscopic hysterectomy: A prospective clinical cohort study.

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.

The Post-COVID 19 long term surveillance study sequel to an add-on Ayurveda regimen.

It has been 18 months now since the world-wide outbreak of COVID 19 (Corona Virus Disease 19) and still the ongoing research is being done for disease specific medicines. During June 2020 to August 2020, an attempt was made to explore if an add-on Ayurveda regimen comprising of Dasamoolkadutrayadi Kashayam and Guluchyadi Kwatham in tablet forms can be prescribed along with standard of care; which has established the clinical evidence that there is advantage of accelerated symptomatic recovery, early discharge from hospital, reducing the duration of hospital stay. After informed consent the patients were followed up over 9 months after discharged from hospital. The purpose of the present extended study was to find the impact of disease even though patients were discharged after appropriate treatment and if there were any late effects in the add-on Ayurveda treatment group after 9 months as it was one of the first few formal studies world-wide; since there was no long term follow up data available. The study concluded that no additional late effects or symptoms or complications which were known in Post COVID phase; were observed in study group who received the add-on Ayurveda regimen as compared to the control group with conventional standard of care.

A prospective clinical study of an Ayurveda regimen in COVID 19 patients.

The ancient Indian system of medicine, Ayurveda has a treatment for symptom complexes of a variety of diseases. One such combination of Ayurvedic medications has potential for use in COVID 19 infection, and hence a prospective study was conducted with this formulation as an add-on, in COVID positive patients in a dedicated COVID hospital. The objective of the study was to evaluate the additional benefit of an Ayurvedic regime in COVID positive patients on the basis of rate of clinical improvement. The Ayurvedic formulation was administered as an add-on to Standard of Care (SoC) in patients with mild to moderate symptoms, in this prospective, open-label, comparative study. Control group received SoC only. Patients receiving Dasamoolkaduthrayam Kashaya and Guluchyadi Kwatham in tablet form in addition to the SoC showed a faster recovery from breathlessness with reduced ageusia. Patients on the treatment group could be discharged earlier than those from the control group. Addition of Dasamoolkaduthrayam Kashaya and Guluchyadi Kwatham to SoC appeared to accelerate recovery of patients hospitalized for COVID 19 infection, in terms of reduction of symptoms and duration of hospital stay.

Outcome of COVID-19 Infection in Cancer Patients in Pune.

Introduction We document our data on the course of the coronavirus disease 2019 (COVID-19) infection in cancer patients in an attempt to help optimize their management in India and globally. Material and Methods Between February 2020 and January 2021, participating oncologists from Pune (members of the Oncology Group of Pune) documented effect of COVID-19 infection in their cancer patients. Binomial logistic regression analysis as well as correlation analysis was done using Pearson Chi-square test to determine significance of clinical factors. Results A total of 29 oncologists from 20 hospitals contributed their data involving 147 cancer patients who developed COVID-19 infections. COVID-19 infection resulted in higher deaths (likelihood ratio of 4.4) amongst patients with hematological malignancies (12/44 = 27.2%) as compared with those with solid tumors (13/90 = 14.4%, p = 0.030). Patients with uncontrolled or progressive cancer (11/34 = 32.4%) when they got infected with COVID-19 had higher mortality as compared with patients whose cancer was under control (14/113 = 12.4%; p = 0.020). Complication of thromboembolic episodes (seen in eight patients; 5.4% cases) was associated with higher risk (25.6 times) of death (five-eighths; 62.5%) as compared with those who did not develop it (20/139;14.4%; p <0.001). Discussion Patients with cancer should be advised to take strict precautions to reduce the risk of being infected with COVID-19. They should also be given priority for COVID-19 vaccination. If infected with COVID-19, patients with hematological malignancy and uncontrolled cancer are at higher risk of morbidity and mortality. When they are being treated (OPD or inpatient basis), additional precautions are necessary to ensure their exposure to potential COVID-19 virus is minimized. If they get infected with COVID-19, they should be given aggressive treatment to prevent complications, especially thromboembolic episodes. If they develop any thromboembolic complication, their risk of dying are significantly higher, and management should be modified accordingly.

Interim safety analysis of the first-in-human clinical trial of the Versius surgical system, a new robot-assisted device for use in minimal access surgery.

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.

Preparedness of Acute Care Facility and a Hospital for COVID-19 Pandemic: What We Did!

BACKGROUND AND AIM: India is facing the pandemic of coronavirus disease (COVID-19) just like the whole world. The private sector is the backbone of a healthcare facility in India. Presently, only a few major hospitals in the country are actively dealing with the COVID-19 patients while others are facing troubles due to lack of manpower, management, and required experience to face the pandemic. Despite the lockdown, the cases are ever increasing and each and every hospital in the country should be prepared to face this pandemic the world has never seen before. As one of the largest multispecialty hospitals and a designated COVID center, we have developed and adopted some strategies for better preparedness to face the surge of this pandemic. We would like to share our experience and hope that the strategies laid down and adopted by us will help many other acute care facilities in many parts of India. MATERIALS AND METHODS: Different strategies are adopted to deal with the crisis situation of the COVID-19 pandemic. Our adopted strategies were directed to mitigate the challenges of administration, hospital space organization, management of staff and supplies, maintenance of standard of care, and specific COVID care and ethics during this pandemic. RESULTS: Based on strategies adopted by us, we feel more confident and prepared to deal with COVID-19 pandemic. CONCLUSION: Our approach for preparing for the COVID-19 pandemic may not be the best one but we believe that the basic managerial principles we adopted will guide many other institutions to find their path in tackling the pandemic in the best possible way. HOW TO CITE THIS ARTICLE: Jog S, Kelkar D, Bhat M, Patwardhan S, Godavarthy P, Dhundi U, et al. Preparedness of Acute Care Facility and a Hospital for COVID-19 Pandemic: What We Did! Indian J Crit Care Med 2020;24(6):385-392.

An Ayurveda Gargle Regimen in Management of Radiotherapy-induced Oral Mucositis.

Background Radiotherapy-induced oral mucositis (RIOM) in patients with head and neck cancer may lead to significant morbidity. OM may result in erythema, ulceration, and pseudomembrane formation. The usual time of onset is second or third week of radiotherapy (RT), after the doses of 16 to 18 Gy. OM may cause severe pain, significant weight loss, increased resource use, interruption or discontinuation of the treatment, and added cost of supportive care. Materials and Methods Patients who underwent RT and chemoradiation (CTRT) for head and neck squamous cell carcinoma (HNSCC) from 2015 to 2016 were included. The patients who were treated with the add-on Ayurveda gargle regimen (AGR) of sapthachhadadi gandoosham were evaluated against patients treated with standard symptomatic care (SSC). Statistical Analysis Chi-square test was used to compare the difference between the two groups in the present study with SPSS (SPSS version 20 for Windows package SPSS Science, Chicago, IL, USA). software. Result Grade III to IV OM was lower in the AGR group when compared with the SSC group ( p < 0.001). Onset of OM was significantly delayed in patients from the AGR group ( p < 0.001). Conclusion The AGR with sapthachhadadi gandoosham is effective in delaying the onset and reducing severity of OM in HNSCC, without compromising the rate of locoregional recurrence.

Efficacy and safety of short course adjuvant trastuzumab combination chemotherapy in breast cancer.

BACKGROUND: The adjuvant short course 9-week trastuzumab combination therapy for human epidermal receptor 2 positive breast cancer patients may often be considered as a cost-effective and safe option and has important implications for the Indian subcontinent as well as other developing countries. However, such regimens of shorter duration trastuzumab therapy like FinHer, offered in view of economic constraints, may not be able to achieve globally comparable cure rates in early breast cancer especially with high-risk women with more than 3 lymph node positive. METHODS AND MATERIAL: Outcome of 21 patients with HER2 positive breast cancer was treated with short course trastuzumab combination chemotherapy in the adjuvant setting was studied. RESULTS: Out of 21 patients 15 are alive and disease free with a follow up of up to 73 months (median follow up 42 months).

Innovative bridging of the rural-urban divide: comparison of scope, safety, and impact of collaborative rural surgery camps and an urban surgical program.

BACKGROUND: In medically under-resourced regions worldwide, non-permanent surgery programs or camps have been conducted to expand access to surgical services. Surgery camp programs have been reported in rural India, primarily in the ophthalmic and obstetric fields; however, the provision of general surgical services in these settings is largely unknown. METHODS: A 12-month retrospective review of non-ambulatory procedures performed at a rural hospital surgery camp program and at an urban hospital in Maharashtra, India, was completed to characterize relative differences in procedural activity, frequency and severity of perioperative complications, and to evaluate efficacy of care. RESULTS: A total of 449 cases performed in rural hospital surgery camps were compared with 344 cases performed in an urban hospital during the course of the study period. The majority of rural surgical cases were elective and of intermediate complexity. Approximately 4% of rural cases were complex-major compared to 17% of urban cases. Intraoperative complications occurred in 0.2% rural cases compared to 5.5% of urban cases; p = 0.01. Postoperative complications were predominantly low grade in both groups. The postoperative complication rate was higher among rural surgical patients (43.4%; 23.5%; p < 0.01), though the Surgical Risk Score was significantly lower in this group (p < 0. 01). Rural surgery camp activity over 12 months achieved diagnostic and/or therapeutic goals in 92.2% of procedures and rendered 1.74-2.69 disability-adjusted life-years (DALYs) averted per patient. CONCLUSIONS: Rural general surgery camps can safely and effectively provide a wide range of surgical services under appropriate collaborative and clinical conditions. Surgery camps may be a safe, temporizing solution to unmet needs until substantial gains in rural healthcare are realized.

Laparoscopic right radical nephrectomy.

Laparoscopic radical nephrectomy is a minimally invasive surgical procedure and is in practice since 1992 in USA. We describe the novel technique of this procedure with an added advantage. Controlling renal vessels first at the hilum with lymphadenectomy is our principle of surgery. This technique is known as transperitoneal medial to lateral approach radical nephrectomy.