Clinical trials

This is a mixed-methods study consisting of a qualitative assessment the acceptability of psychosocial interventions, delivered by clinical staff. The study will also investigate the correlation between demographic variables and engagement with a North West England, NHS-led, alcohol care service, amongst the patient population.

Achilles tendinopathy is a common condition that causes pain and stiffness in the tendon at the back of the ankle. It can make walking, exercise, work, and everyday activities difficult. The main recommended treatment is a programme of progressive tendon-loading exercises, usually supported by an NHS physiotherapist. These exercises can help improve pain and function, but many people find them hard to continue over time. This means that, even though the treatment can work well, some people do not get the full benefit because they are unable to keep up with the exercise programme as advised. People with Achilles tendinopathy often describe worries about making the tendon worse, uncertainty about whether pain during exercise is safe, low confidence, slow progress, and difficulty fitting exercises into daily life. These challenges may be even greater for people from underserved groups, including those living with long-term health conditions, financial pressures, language barriers, or other forms of disadvantage. At present, there is limited research exploring these experiences in a structured way, especially in routine NHS care. The aim of this study is to understand what helps or makes it harder for people to stick with NHS-prescribed progressive tendon-loading exercises for Achilles tendinopathy. The study will focus particularly on the experiences of people who may be at higher risk of poor outcomes or reduced access to support. Up to 30 adults with experience of Achilles tendinopathy and previous NHS physiotherapy treatment will take part in a one-to-one interview. Interviews will last up to 45 minutes and can take place in person, online, or by telephone, depending on what suits the participant best. Participants will be asked about their experiences of living with Achilles tendon pain, being given exercise treatment, and trying to follow that treatment in everyday life. The information from these interviews will be analysed to identify the main barriers and supports affecting exercise adherence. The findings will be used to build a clearer understanding of the behavioural factors that influence whether people are able to continue with treatment. This will help inform the future development of a targeted support approach to improve adherence to exercise-based rehabilitation for Achilles tendinopathy in NHS practice. The long-term goal of the study is to help make treatment more effective, more personalised, and more suitable for people from a wide range of backgrounds, including those whose needs are often overlooked in research and healthcare design.

Pre-operative biliary drainage (PBD) is a procedure used to relieve bile duct obstruction, a common issue in patients with pancreatic cancer. The obstruction occurs when a tumor blocks the bile duct, leading to jaundice and other complications. While PBD can help resolve jaundice and improve liver function, its impact on the overall outcomes of pancreatic cancer surgery is still debated. Recent research has focused on whether PBD before surgery improves patient outcomes, such as surgical success, recovery time, and long-term survival. Some studies suggest that draining the bile before surgery might reduce complications like infections, liver dysfunction, and jaundice-related risks. On the other hand, other research indicates that PBD could increase the chances of infection, delays in surgery, or complications from the procedure itself, such as bile leakage or inflammation. This study will look at patients undergoing pancreaticoduodenectomy to remove their head of pancreas pancreatic ductal adenocarcinoma over 8 years, and will compare the tumour characteristics of patients who have had PBD vs those who have not. Data will be gathered from the already available histological characteristics. No treatment would be affected and no tissue would be affected. This research study will focus on oncological characteristics such as tumour progression and lymphatic spread, with overall patient survival as secondary outcome measures.

1. FULL TITLE OF THE PROJECT Should we use post-operative antibiotics following surgery for patients with mandible fractures? The MANTRA trial (MANdibular TRauma and Antibiotic use) 2. SUMMARY OF RESEARCH (ABSTRACT) Research Question: Are post-operative antibiotics required following surgery for patients with mandible fractures? Background: Mandible fractures are the commonest facial fractures needing surgery and account for a significant percentage of the acute workload in Oral \& Maxillofacial Surgery (OMFS) units. The UK records over 6000 new cases per year. Patients having surgery for mandible fractures have a theoretical risk of developing surgical site infection, due to the proximity of the fracture lines to the oral cavity microbes and the presence of foreign body (titanium fixation miniplates). For this reason, clinicians often prescribe antibiotics after surgery, to reduce the risk of infection. Previous systematic reviews and a multicentre cohort study performed by this team, revealed significant clinical variation in post-operative antibiotic prescription amongst UK OMFS clinicians and the presence of clinical equipoise. Antibiotic overuse can lead to antibiotic resistance and other antibiotic-related side effects; judicious antibiotic use and stewardship is of paramount importance. Aim: To determine whether post-operative antibiotics are required at all, following surgery for mandible fractures, and, if so, what is the most clinically- and cost-effective regimen Objectives: Primary Objective To conduct a Randomized Controlled Trial (MANTRA) in order to establish the non-inferiority (or not) of not giving post-operative antibiotics versus 2 other post-operative antibiotic regimens. An internal pilot phase will optimise recruitment and retention. Secondary Objectives * Measure the cost-effectiveness of the proposed antibiotic pathways * Assess patient and clinician acceptability to change clinical practice * Process evaluation to inform dissemination and implementation Methods: The investigators designed and propose the MANTRA RCT to compare 3 post-operative antibiotic approaches to prevent Surgical Site Infections (SSIs) following surgery for mandible fractures. The MANTRA trial is a large open label, multicentre study in NHS OMFS units. The 3 study arms represent the most common clinical pathways in the UK based on previous work; the control group is the approach prescribed by most UK OMFS clinicians. All patients will receive 1 dose of IV antibiotics (co-amoxiclav 1.2g, if no penicillin allergy, which is the most commonly used prophylactic antibiotic currently) on induction of anaesthesia, prior to their surgery. The participants will be randomised to the following (1:1:1): Group A: No further antibiotics Group B: 2 further postoperative IV doses of co-amoxiclav 1.2g Group C: 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy (Control). Trial processes will be optimised by an internal pilot phase ensuring we recruit, randomise, and retain participants with clear progression criteria. We will also conduct cost-effectiveness analyses and process evaluation for dissemination and implementation Timeline: Start of grant: 1st July 2023 Start of RCT / pilot: 1st January 2024 End of pilot: 30th June 2024 End of recruitment: 31st December 2026 End of follow-up: 30th June 2027 Completion: 31st December 2027 Impact and dissemination: * Practice changing outputs that standardise the use of antibiotics in mandible fractures in the NHS and provide a framework for other surgical prophylaxis research * A bespoke clinical dissemination plan via an engagement and training legacy * Cost-effectiveness data to inform policy making * A research legacy and change of culture in the specialty of OMFS

It is a qualitative study, using semi structured interviews to explore patient's experiences of falls and their perceptions on facilitators and barriers to exercise. Aim: To explore reasons for and against engaging with exercises at home in participants over the age of 60 at risk of falls. To explore: 1. Patients' preferences to exercise format and type eg/ leaflet, online, access, such as the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or individual personalized rehabilitation programme handouts 2. The ability to discuss falls risk with health professionals. 3. If health inequalities exist with people at risk of falls and exercising. 4. Sustainability of exercise, in order to reduce the risk of falls in this population. 5. The need to develop MSK internal and external facing falls management pathways. Suitability: Patients over the age of 60, who have been identified at risk of falls, having been referred to MSK Physiotherapy in Rossendale. 'Risk of falls' is defined as: patient self-reports they are unsteady, had one or more fall in the last 6 months, or clinician identified a slow/unsteady gait pattern on examination. Semi structured interviews on up to ten participants. It is anticipated that this sample size will give adequate data saturation. Approximately 12 months from participant recruitment to analysis of findings.