Serbian National Training Programme for minimally invasive colorectal surgery (LapSerb): short-term clinical outcomes of over 1400 colorectal resections.

INTRODUCTION: The Serbian National Training Programme for minimally invasive colorectal surgery (LapSerb) was introduced to implement laparoscopic colorectal surgery across Serbia. The programme aimed to accelerate training of established colorectal surgeons through a competency-based programme. This involved knowledge assessment, workshops, live operating, and competency-based assessment of unedited videos. The aim of this study is to report the outcomes of laparoscopic colorectal resection performed by LapSerb certified surgeons. METHODS: LapSerb prospectively maintained multicentred database was analysed for laparoscopic colorectal resections from January 2015 to February 2021. Data collected included patient demographics, indications for surgery, perioperative data, and 30-day outcomes. RESULTS: A total of 1456 laparoscopic colectomies by 24 certified surgeons were included in the final analysis. Mean age was 67 (± 12) years old and male to female ratio was 1:1.5. 83.1% of the colectomies were malignant, mainly due to adenocarcinoma. Anterior resection was the most common procedure with 699 (48%) cases, followed by right and left colectomies with 357 (24.5%) and 303 (21%) procedure respectively. 4.8% of patients required conversion to open surgery. Thirty-day readmission and reoperation rates were 2.3% and 4.7%, respectively. Overall mortality in all cases was 1.1% and R0 resections were achieved in 97.8% of malignant colectomies. CONCLUSION: The LapSerb programme successfully and safely established laparoscopic colorectal surgery across the country with comparable and acceptable short-term clinical outcomes.

Virtual Reality as a Surgical Care Package for Patients Undergoing Weight Loss Surgery: A Narrative Review of the Impact of an Emerging Technology.

While bariatric surgery is regarded as the most effective treatment for people with severe and morbid obesity, its pathway is regarded as a complex one due to the multidisciplinary approaches required from pre-surgery education until long-term management. This is essential to maintain weight loss and improve the quality of life after bariatric surgery. Although these approaches are broadened, patient education, pre-operative preparation, behavioural therapy, rehabilitation, and dietary changes are regarded as the main domains in such complex care. With the increase in technological adaptation in medical services, virtual reality (VR) has shown many benefits that can be utilized in the care of bariatric patients undergoing surgery. However, VR has not been innovated to be a multidomain care package in which bariatric patients could benefit throughout their journey from the pre-operative optimization, recovery, and long-term follow-up. This review aims to give a brief description of some of the applications of VR technology and question whether it has the potential to be considered as a virtual ecosystem to improve the bariatric patients' experience and pathway throughout surgery and follow-up.

A light-weight compact proton gantry design with a novel dose delivery system for broad-energetic laser-accelerated beams.

Proton beams may provide superior dose-conformity in radiation therapy. However, the large sizes and costs limit the widespread use of proton therapy (PT). The recent progress in proton acceleration via high-power laser systems has made it a compelling alternative to conventional accelerators, as it could potentially reduce the overall size and cost of the PT facilities. However, the laser-accelerated beams exhibit different characteristics than conventionally accelerated beams, i.e. very intense proton bunches with large divergences and broad-energy spectra. For the application of laser-driven beams in PT, new solutions for beam transport, such as beam capture, integrated energy selection, beam shaping and delivery systems are required due to the specific beam parameters. The generation of these beams are limited by the low repetition rate of high-power lasers and this limitation would require alternative solutions for tumour irradiation which can efficiently utilize the available high proton fluence and broad-energy spectra per proton bunch to keep treatment times short. This demands new dose delivery system and irradiation field formation schemes. In this paper, we present a multi-functional light-weight and compact proton gantry design for laser-driven sources based on iron-less pulsed high-field magnets. This achromatic design includes improved beam capturing and energy selection systems, with a novel beam shaping and dose delivery system, so-called ELPIS. ELPIS system utilizes magnetic fields, instead of physical scatterers, for broadening the spot-size of broad-energetic beams while capable of simultaneously scanning them in lateral directions. To investigate the clinical feasibility of this gantry design, we conducted a treatment planning study with a 3D treatment planning system augmented for the pulsed beams with optimizable broad-energetic widths and selectable beam spot sizes. High quality treatment plans could be achieved with such unconventional beam parameters, deliverable via the presented gantry and ELPIS dose delivery system. The conventional PT gantries are huge and require large space for the gantry to rotate the beam around the patient, which could be reduced up to 4 times with the presented pulse powered gantry system. The further developments in the next generation petawatt laser systems and laser-targets are crucial to reach higher proton energies. However, if proton energies required for therapy applications are reached it could be possible in future to reduce the footprint of the PT facilities, without compromising on clinical standards.

Recommendations for clinical biomarker specimen preservation and stability assessments.

With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a 'standardized process' for ensuring biomarker specimen stability and hence, a strong desire to share best practices on preserving the integrity of biomarker specimens in clinical trials and the design of studies to evaluate analyte stability. By leveraging representative industry experience, we have attempted to provide an overview of critical aspects of biomarker specimen stability commonly encountered during clinical development, including: planning of clinical sample collection procedures, clinical site training, selection of sample preservation buffers, shipping logistics, fit-for-purpose stability assessments in the analytical laboratory and presentation of case studies covering widely utilized biomarker specimen types.

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.

Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed assays leading to various adjustments for validation and potentially during sample analysis to accommodate all of the analytes being measured. This often requires a compromise in decision making with respect to choosing final assay conditions and acceptance criteria of some key assay parameters, depending on the intended use of the assay. The critical parameters that are impacted due to the added challenges associated with multiplexing include the minimum required dilution (MRD), quality control samples that span the range of all analytes being measured, quantitative ranges which can be compromised for certain targets, achieving parallelism for all analytes of interest, cross-talk across assays, freeze-thaw stability across analytes, among many others. Thus, these challenges also increase the complexity of validating the performance of the assay for its intended use. This paper describes the challenges encountered with multiplex LBAs, discusses the underlying causes, and provides solutions to help overcome these challenges. Finally, we provide recommendations on how to perform a fit-for-purpose-based validation, emphasizing issues that are unique to multiplex kit assays.

Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development.

Increasingly, commercial immunoassay kits are used to support drug discovery and development. Longitudinally consistent kit performance is crucial, but the degree to which kits and reagents are characterized by manufacturers is not standardized, nor are the approaches by users to adapt them and evaluate their performance through validation prior to use. These factors can negatively impact data quality. This paper offers a systematic approach to assessment, method adaptation and validation of commercial immunoassay kits for quantification of biomarkers in drug development, expanding upon previous publications and guidance. These recommendations aim to standardize and harmonize user practices, contributing to reliable biomarker data from commercial immunoassays, thus, enabling properly informed decisions during drug development.