Best care for patients is discovered from randomised clinical trials, but few patients undergoing an operation are given the opportunity to enter one. We aim to create a culture where all patients are given this chance. In this project, we will test whether senior medical students (one year from becoming doctors) can be trained to recruit patients to clinical trials, in order to create a generation of research-ready junior doctors. We believe that equipping medical students with the requisite practical skills for recruitment of patients into clinical trials will be a major step forward for evidence-based clinical practice in the UK.
These are the research projects that BDRF have funded.
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Hartmann’s procedure versus intersphincteric abdominoperineal excision: a prospective observational study
14,000 cases of rectal cancer are diagnosed annually in the UK. Gold standard treatment is surgical removal of the rectum and reconnection of the bowel ends, for an increasing frail/elderly population this is sometime not safe, and surgeons choose one of two alternatives, which avoid a surgical join. Hartmann’s procedure (HP) or intersphincteric APE (IAPE) both remove the tumour and either remove (IAPE) or leave the anal canal in place (HP). Although traditionally viewed as being safe, HP still has a high risk of surgical complications due to pelvic infections arising from the remaining anal canal and many surgeons have now stopped performing this procedure. However, 50% of UK surgeons (unpublished data) still choose HP due to lack of data and concerns over damage to the tumour during IAPE. Surgeons that use IAPE often modify their technique to reduce this risk, and we would like to convince the remaining surgeons to change from HP to IAPE. A randomised trial is not feasible due the difficulty in randomisation, and routine NHS datasets are not detailed enough to help.
Development of an IDEAL framework to standardise the complex intervention of cytoreductive surgery for colorectal peritoneal metastases: a necessary step to phase III trials
Cytoreduction surgery (CRS) followed by hyperthermic intraoperative peritoneal chemotherapy (HIPEC) is a relatively new intervention in selected patients with peritoneal metastases of colorectal origin (PMCR). Data from outside of trials suggest that CRS and HIPEC improves survival compared with the current standard care (systemic chemotherapy). The big challenge is to do trials in this setting – as the intervention is complex, and there are wide variations in the process and recording of outcomes. If trials confirm findings from non‐randomised studies there are an estimated 1000 to 2000 patients who may benefit from this intervention in the UK each year. The overarching aim is to develop a robust and reproducible framework in which to undertake a phase III trial in patients with PMCR suitable for CRS with or without HIPEC.
(A multi-centre randomised phase II feasibility study to determine) which patients with intermediate stage rectal cancer need radiotherapy before surgery and which can safely have surgery alone
There are 14,000 newly diagnosed rectal cancers in the UK each year and 40 per cent of these are locally advanced. Current guidelines suggest that most locally advanced rectal cancers should receive both chemotherapy and radiotherapy (CRT) before surgery to reduce the risk of relapse. There are, however, downsides to the radiotherapy which include early and late side effects (bowel, bladder and sexual problems) and surgical complications. Surgical technique and tumour imaging by MRI scan have improved greatly so that good cancer outcomes are being reported in patients who do not receive radiotherapy.
(Many people are now referred to hospital on suspicion of bowel cancer but fewer than 1 in 16 will prove to have the disease.) Will a simple and inexpensive urine test enable us to identify those most likely to have bowel cancer, and then fast track them for diagnostic tests and, if needed, treatment?
Colorectal cancer is the second commonest cause of cancer deaths in the UK. Government has therefore introduced several initiatives to encourage earlier presentation. This has led to a rapid increase in the number of patients referred via the two week wait (TWW) referral pathway on suspicion of bowel cancer. Of those referred, more than 3 in 4 will need a colonoscopy and over 1 in 4 a CT scan, but fewer than 1 in 16 will have bowel cancer. Patients are not currently risk stratified to ensure those at most risk of having cancer have their colonoscopy first. Pressure on diagnostic services due to the high number of patients referred leads to frequent breaches of official waiting targets for patients with colon cancer. If we had a simple and reliable test to identify those at most risk of having bowel cancer, such patients could have their colonoscopy within a week, enabling quicker diagnosis and earlier treatment for those with colon cancer. This will certainly improve their “patient journey” and may produce better cancer outcomes.
A study to find out if the presence and activity of a specific group of cells forms the mechanism whereby removal of the appendix has beneficial effects on Ulcerative Colitis
Ulcerative Colitis (UC) is a chronic inflammatory condition of the large bowel affecting about 140,000 people in the UK, of whom around 40% experience a relapse annually. Several small studies in patients with active UC have found that removing the appendix may reduce relapse, hospitalisation and medication usage, with the potential to also prevent the need for future major surgery. The mechanisms by which the appendix interacts with bowel inflammation in UC to exert these beneficial effects are not yet fully understood. We have a specific theory to test, which centres on the presence and activity of a specific group of immune cells (called gut-homing Mucosa-Associated Invariant T cells, or MAIT). No other group anywhere in the world has ever explored the relationship of the appendix and MAIT cells in UC.
Does the protein p16 have predictive value in helping/enabling us to personalise how much chemo-radiotherapy to give individual anal cancer patients?
Anal Cancer is increasingly common and now affects 1,200 patients a year in the UK. Currently all patients are treated in a standard fashion, using a combination of chemotherapy and radiotherapy. Although this gives 3-year disease free survival of over 70%, some patients cannot tolerate this treatment while others are not cured by it. Therefore, both improved predictive markers and treatments are urgently required. This project aims to improve our prediction of response to treatment allowing personalisation of treatment.
Does the level of a specific protein predict the effectiveness of radiotherapy in rectal cancer? Also, will altering the level of this protein improve response to radiotherapy?
Chemo- and radiotherapy (or CRT) is commonly used in rectal cancer before surgery. Some patients respond well to this treatment and have a “complete response”. However, this preferred outcome is at one end of a spectrum of response and all patients are at potential risk of side effects. Patients who respond well to radiotherapy have better outcomes and a wider range of subsequent management options available. We do not currently know why there is this difference in response, and predicting response is not yet possible.
Developing a new assessment tool (for eventual worldwide use) to evaluate the impact of medical and surgical treatments for those Crohn’s Disease patients who develop fistulae
In the UK up to 100,000 people have Crohn’s Disease, with between 3,000 and 6,000 new cases a year. One in three Crohn’s patients can develop an anal fistula (an abnormal channel between the inside of the bottom and the outside skin). The causes are not completely known and the condition is hard to treat; its effects on patients’ psychosocial wellbeing are immense. We have done a lot of work looking at causes and treatments. We now want to create an assessment tool to help both doctors and patients by evaluating the medical problem and the quality of life of those who have fistulas. We will also use this tool to check the impact of medical and surgical treatments.
Feasibility of intraluminal imaging of blood perfusion for the evaluation of colorectal anastomosis in rectal cancer
A leak from a bowel join is a significant problem to [the MH] patient in terms of health implications and long term survival. Health institutions likewise are strained as a result of this relatively common complication. Identifying patients likely to leak after surgery will help us adopt strategies to reduce the complications and associated health care costs.