Clinical trials

This study is designed to evaluate the application of the Maestro Robotic Platform for surgical assistance in laparoscopic abdominal surgery. The purpose of this study is to assess the system use in general surgery on different procedures, level of complexity, and type of setting (elective/emergency).

Robotic surgery in the UK is now widely used in elective procedures based on evidence that it can improve outcomes, with improved vision and precision for the surgeon resulting in better results and greater rates of minimally invasive surgery. Despite this, there remain some concerns about its use with some saying it adds cost with limited or no benefit to patients. Its application in the emergency setting has not been well studied. However, emergency patients are the sickest patients, and so stand to potentially gain the most from robotic surgery, if it is shown to be beneficial by enabling more precise surgery. The investigators aim to evaluate the impact of robotics in emergency general surgery, on outcomes, patients, and surgeons as well as the greater health system. Given the need for modern health systems to reflect the needs and desires of their users, the investigators also aim to explore patient and surgeon preferences and priorities in emergency surgery with particular reference to surgical approach (open/laparoscopic/robotic).

Prosthetic joint infection (PJI) is a significant cause of failure in hip and knee arthroplasty and is often difficult to diagnose using current methods. This study aims to identify novel biomarkers for early and accurate diagnosis of PJI using nanopore sequencing technology (Oxford Nanopore Technologies). By analysing microbial profiles and host immune responses in samples from patients undergoing revision surgery, the study will compare infected and non-infected cases. Biomarkers will be investigated in periprosthetic tissue as well as less invasive sample types, including synovial fluid and blood, with the goal of improving early diagnosis and guiding future treatment strategies.

This study, delivered by Portsmouth Hospitals University NHS Trust in conjunction with the Research Group in Breast Health at the University of Portsmouth \[1\], aims to assess whether it is possible to test breast biomechanics in women who have had surgery with or without radiotherapy for the treatment of breast cancer.

This is a single-center, randomized controlled, parallel, non-inferiority trial. All adult patients with benign gallbladder disease with an indication for cholecystectomy will be assessed for eligibility and included after obtaining informed consent. A total of 276 patients will be randomized to undergo either robotic cholecystectomy (RC) or laparoscopic cholecystectomy (LC). The primary endpoint will be the incidence and severity of postoperative complications within 30 days after surgery. Secondary endpoints include perioperative outcomes, total health care utilization, health-related quality of life (HR-QoL) as assessed by patient-reported outcome measures, and cost-effectiveness. Follow-up assessments will be conducted at 7 and 30 days postoperatively. This is the first randomized controlled trial designed to compare RC with LC in the treatment of benign gallbladder disease. The trial aims to evaluate the safety and non-inferiority of RC relative to LC, providing important evidence to guide the progress and adoption of robotic surgery in clinical practice.

Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems.

This study aims to assess the concordance of international asthma guidelines in the diagnosis of asthma and explore the presence of airways disease using additional non-guideline physiologic criteria, such as IOS (impulse osciollometry), not included in the guidelines, but available in the Portsmouth lung function service.

Current virus detection methods often take significant time or can be limited in sensitivity, specificity or cost. There is therefore a need for diagnostic methods that are simple to use, sensitive, rapid and inexpensive. This is a proof of concept study to determine whether the Pictura Bio system (a new a rapid pathogen identification technology) is able to detect and differentiate different viruses from nasopharyngeal swabs/aspirate specimens. The data collected will be used to "train" the algorithms to be able to accurately identify respiratory viruses. The accuracy with which the algorithms estimate the test dataset will be monitored at regular intervals during the training dataset collection period. The Pictura Bio system is still under development, which means that it is still "learning". The system needs to see more information so that it can be sufficiently accurate to be used in clinical practice and should become more accurate in identifying these viruses as it sees more and more information from patients. This study will take place at Portsmouth Hospitals University NHS Trust and aims to recruit 1000 patients. To do this, we will recruit both adults and children who either present to the emergency department or are admitted to QAH with a clinical suspicion of a respiratory viral infection. All participants will have a nose and/or throat swab taken as part of their clinical assessment, and we would ask to take a further nasal swab for the purpose of the study. Research sampling will be combined with routine clinical samples where possible to reduce the frequency of testing. We will use most of the information to teach the system how to become more accurate at identifying respiratory viruses. We will keep the remaining information separate and use it to test how accurate the system is. All of the data will be kept securely. Basic information will be collected including age, gender, results of blood tests taken for clinical review, treatment and outcome data. No results from the swabs taken for the purpose of the study will be available to either the participant or the clinical team and the information will have no effect on patient care.

Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.

This study will provide valuable insights into the demographics of MyRenalCare users, their digital adherence, and the overall impact of the app on health outcomes, healthcare costs, and environmental sustainability.

This trial aims to evaluate novel diagnostic technologies for asthma in 3 different pathways providing the necessary evidence-base to allow adoption into clinical practice: * Pathway 1 evaluates whether the technology can distinguish between people with asthma and healthy volunteers, and other respiratory conditions in a well characterised secondary-care population and whether the parameters they measure correlate with the current standard diagnostic tests; * Pathway 2 assesses whether the technology can accurately diagnose asthma (either independently or alongside current diagnostic tests) in a primary care population of patients where there is a clinical suspicion of asthma; * Pathway 3 explores the ability of the technology to identify clinically important phenotypic characteristics which are difficult to measure in primary care and/or significantly impact on patient management and treatment The novel technology and devices will be entered into the pathway most suited to their stage of development, with this study design also allowing information collected for participants with a confirmed diagnosis of asthma in pathways 1 or 2 to be included in pathway 3. Participants will undergo the investigations currently used to diagnose asthma as well as using the novel devices being investigated in the relevant pathway.

An integrated database of depersonalised routine hospital patient data consisting of demographic and disease attributes, physiological or laboratory measurements, care contacts and interventions along with associated clinical outcomes. The database is an essential resource for the development and testing of risk models and classification systems, modified as necessary for patient subgroups, which can then be introduced into clinical care to improve patient outcomes. It can also be used for large scale simulations to evaluate interventions.

Lung cancer remains the leading cause of cancer-related death in the UK, with over 35,000 deaths annually and most cases diagnosed at a late stage. Current screening programmes using low-dose CT scans target only high-risk individuals, missing around 30% of lung cancer cases, including many women and never-smokers. There is no simple, non-invasive tool to help triage patients with persistent respiratory symptoms who fall outside formal screening criteria. Inflammacheck® measures hydrogen peroxide and other breath biomarkers linked to airway inflammation and oxidative stress. Preliminary studies (VICTORY and ExPeL) have shown strong diagnostic performance for distinguishing lung cancer from other respiratory conditions. VICTORY 2 aims to validate and refine the AI model supporting Inflammacheck®, enabling accurate, rapid, and affordable triage for suspected lung cancer in NHS settings.

Multicentre, observational registry studying the natural course of polycystic liver disease.