Doctor talking to patient

Colorectal Completed Research

The Colorectal Research team at North Bristol NHS Trust offer patients and people at risk of developing Colon cancer excellent patient-centred care and the opportunity to participate in research.

Delivering complex interventional and observational studies, the team is comprised of  a multidisciplinary clinical team, supported by our research nurses and a Research Administrator. 

Please speak to the person treating you to see if there is a research study that may be able to help you.

Studies in follow-up:

CIPHER – UK Cohort study to Investigate the prevention of Parastomal Hernia

The CIPHER study aims to establish the incidence of symptomatic and radiologically confirmed PSH during a minimum of 2 years follow up. Additionally, CIPHER aims to evaluate the effects of key technical surgical steps during index stoma formation on the risk of subsequent PSH formation. (PSH – Parastomal Hernia)

The target population is adults (18+ years) undergoing elective or expedited surgery, i.e planned operation, with the intention to form a stoma, irrespective of the primary indication for the planned surgery (e.g., colorectal cancer, inflammatory bowel disease).

Modification of the technical aspects of surgery may reduce the incidence of PSH and could lead to improvements in the health of patients, better quality of life, a reduction in direct stoma appliance and accessory costs and fewer PSH repairs. The modifications offer the potential for significant savings for the NHS as well as benefit for individual patients. Unfortunately, existing studies on surgical technique relating to stoma formation are limited by poor design and generalisability and, consequently, further high-quality research is urgently needed.

CIPHER will attempt to address this evidence gap.

Project Details
Principal Investigator: Ms Ann Lyons
Study Completion: 30/11/2021
Local Ref: 4186

Completed Studies:

FOxTROT

FOxTROT is a randomised trial aiming to establish whether giving the first 6 weeks of combination chemotherapy prior to surgery improves the probability of cure for patients with high-risk operable colon cancer, and whether adding the anti-EGFR monoclonal antibody panitumumab to neoadjuvant therapy, in patients with RAS-wildtype tumours, improves response. In addition, FOxTROT’s neoadjuvant therapy evaluation provides a unique opportunity for translational research to identify tumour markers predictive of response to cytotoxic and anti-EGFR therapy.

Any patient whose standard treatment is likely to comprise surgery followed by adjuvant oxaliplatin/FU combination chemotherapy should be considered for inclusion in FOxTROT. Entry is based on a CT scan staging algorithm, which identifies patients whose disease is locoregionally advanced, and therefore at significant risk of relapse following standard treatment. If allocated pre-operative chemotherapy, the first 6 weeks are given preoperatively and the rest of the course is given postoperatively. If allocated standard chemotherapy, the whole course is given postoperatively.

Project Details
Principal Investigator: Ms Ann Lyons
Study Completion: 31/12/2019
Local Ref: 2064

The effect of metformin and physical exercise on the IGF pathway in colorectal cancer patients

To investigate whether the cellular staining and localisation of b-catenin and FOXO3a in tumour sections excised from patients with CRC is altered in patients taking metformin or affected by physical activity. We will also examine whether activation of PI3K occurs in tumours due to direct mutation, loi of IGF-II or loss of PTEN and how this then affect the levels and location of b-catenin, FOXO3a and E-cadherin. We will then be able to assess whether the effects of metformin or physical activity are affected by the status of the PI3K pathway.

Using CRC cell lines we will also examine whether exposure to metformin and hormones related to physical activity (irisin and adiponectin (known to activate AMPK)) results in activation of AMPK and altered location of FOXO3a and b-catenin. We will then examine changes in expression of b-catenin target genes and cell responses in terms of cell survival and cell motility/migration.

Project Details
Principal Investigator: Ms Kathryn McCarthy
Study Completion: 31/03/2020
Local Ref: 3152

ARISTOTLE

A phased III trial comparing standard versus novel chemoradiotherapy as preoperative treatment for MRI defined locally advanced rectal cancer.

Rectal cancer affects 10,000 new patients per year and causes 4,700 deaths each year in England and Wales. Radiotherapy has a major role in reducing the risk of local failure and shrinking locally advanced cancers to facilitate a curative resection. The use of pre-operative MRI can identify patients who have locally advanced rectal cancer who would benefit from pre-operative chemo-radiotherapy (CRT). The proposed randomised controlled trial will investigate whether the addition of a second chemotherapy drug will further improve disease free survival and loco-regional control.

There is a clear established role for the use of neoadjuvant radiotherapy in resectable rectal cancer.

Project Details
Principal Investigator: Ms Ann Lyons
Study Completion: 29/12/2023
Local Ref: 3146

Defining the Denominator – ELF2

Patients can develop conditions that require treatment by an emergency operation called a laparotomy. The National Emergency Laparotomy Audit (NELA) was set up and this has improved the outcomes from surgical units performing emergency laparotomies. NELA has improved the care of patients before and after their laparotomy, and thus improved UK wide outcomes. When patients become older and have more medical conditions, they can become frail.

Frailty is not just a measure of age, but of a person’s general health and independence and is a range. Being frail makes it more difficult to recover from an illness and operations. A previous research study (ELF), undertaken by researchers involved in this study, found that those patients with a higher frailty score had more problems recovering from an emergency laparotomy, stayed in hospital longer and had decreased rate of going home after the operation.

However, there is a group of patients that very little is known about, the older patient that requires a laparotomy as treatment for their emergency condition but do not have the emergency laparotomy (NOLAP). There is little information and research into the total number who not undergo laparotomy, and reasons for not having a laparotomy, frailty and outcomes for these patients. A smaller study has suggested that a third of patients that do not have a laparotomy are alive and well at one month. This multi-centre UK study aims to compare the data from those that do not undergo

laparotomy with those that do in the older patients. The findings of this study will be used to improve the shared decision making process in this group of patients by providing relatable information to patients but to also improve the patient care and resources available to the patients.

Project Details
Principal Investigator: Ms Kathryn McCarthy
Planned End Date: 01/09/2021
Local Ref: 4710

Consider19

The COVID-19 (coronavirus) pandemic has changed how NHS care is delivered. The surge of critically unwell patients has led to many services being cancelled or postponed, including planned operations for bowel cancer. Usual approaches to treating bowel cancer have also needed to adapt for safety reasons, to reduce the risk of exposing patients to COVID-19. However, a short pause or change to normal bowel cancer services can also have potentially serious effects on patients’ quality of life and survival.

While the peak of infections may have passed, resuming normal NHS services will take time. The NHS recommends a system to prioritise patients, to ensure those most in need receive their operation first. There will, however, be a backlog of patients awaiting surgery, and some may be offered non-surgical or palliative care. Healthcare professionals need to clearly communicate information about delays and changes to bowel cancer treatment with patients. These conversations can be complex, but it is important they are delivered well, so that patients can make informed decisions and adhere with clinical recommendations.

The aim of this project is to investigate how decisions about the surgical management of bowel cancer are formulated and communicated with patients as the COVID-19 pandemic evolves. We intend to interview clinical professionals about the changes to colorectal cancer services since the onset of the pandemic, and audio-record their clinical consultations with patients. Eligible patients include individuals with a diagnosis of bowel cancer, who are candidates for surgical intervention, or have undergone surgical intervention over the course of the study period. We also intend to interview patients, to investigate their perspectives on their care, and the information communicated to them by clinical professionals.

The study will last 10 months and will take place across at least 3 NHS hospital Trusts in England.

Project Details
Principal Investigator: Ms Anne Pullybank
Planned End Date: 31/05/2021
Local Ref: 4875

DISCOVER – DetectIon of Symptomatic COlorectal cancer using VolatilE biomaRkers

DISCOVER was a prospective, multi-centre diagnostic accuracy study which involved 600 patients referred via the fast track pathway for suspected colorectal cancer. The study took place at 3 sites over 18 months, in which time Southmead recruited a massive 237 patients!

Early detection and treatment of bowel cancer is important as it improves survival which has led to a “fast-track” system to reduce waiting times and improve access to hospital tests. Deciding who to test is hard for GPs and hospital doctors because bowel symptoms are common and are not usually due to cancer. Therefore, at present the majority of patients are required to undergo testing if they report bowel symptoms. A colonoscopy is the best way to look at the large bowel, however, this test invasive. Strong laxatives are needed to prepare the bowel and there is a risk of unplanned admission to hospital and surgery. In the UK, 300,000 people a year are referred through the fast-track system but over 90% have normal results meaning they have undergone unpleasant testing unnecessarily.

Patients referred with suspected colorectal cancer were asked to provide a urine sample for analysis of volatile compounds (VC’s). VC’s are natural chemicals caused by normal bacteria in the colon which can be changed by cancer. There is increasing evidence that VC profiling can be used for colorectal cancer detection.

DISCOVER aimed to determine the sensitivity and specificity of urinary VC analysis for the detection of colorectal cancer and polyps in hopes of safely reducing the number of patients undergoing unpleasant bowel tests without missing important diagnoses

Project Details
Principal Investigator: Miss Anne Pullyblank
Planned End Date: 30/09/2019
Local Ref: 4317

SELFI WOUND – Self-taken images of surgical wounds

Infection of the wound after surgery (surgical site infection; SSI) is problematic for patients and expensive to the health service. Monitoring how the wound is healing and signs of infection is therefore high priority for patients, for health services and for research. Accurate assessment of wounds is challenging because many problems occur after the patient has left hospital. The aim of the SELFI WOUND study was to see if it is possible for people to take a clear photograph of their wound after they have left hospital using their own digital camera and mobile device (e.g. mobile phone or tablet computer) and if so, could be a useful method to use in research studies and everyday care to help assess how the wound is healing after people have left hospital.

Southmead recruited 57 patients for to study.

Project Details
Principal Investigator: Miss Anne Pullyblank
Planned End Date: 10/06/2019
Local Ref: 4263

BLUBELLE – A feasibility study of complex, simple and absent wound dressings in elective surgery (Phase B)

A wound dressing is a product placed over a wound that has already been closed (e.g. with stitches or clips). There are many different types of wound dressings that can be used following common operations. Most are simple and inexpensive, similar to a large plaster.  Alternatively, the surgeon can spread a transparent film called tissue adhesive along the length of the wound, referred to as ‘glue-as-a-dressing’. A third possibility is for no dressing to be used at all and is common for certain operations. At the moment, nobody knows whether it is better to have a simple dressing, glue-as-a-dressing or no dressing.

The Bluebelle study was a small study to find out if a larger study comparing different types of wound dressings would be feasible. The larger study could provide high quality information about the best way to dress surgical wounds following common operations involving the stomach.  In this study, we invited patients to be assigned to have simple dressings, glue-as-a-dressing or no dressing on their wounds.

The primary aim was to find out whether assignment to one of these options is acceptable and whether staff use the assigned type of dressing (i.e. avoid reverting to the way they usually dress wounds). This was important so that the research team could judge whether it would be possible to conduct a full scale study.  

Southmead recruited 149 patients to this study.

Project Details
Principal Investigator: Prof Tim Draycott & Miss Anne Pullyblank
Planned End Date: 03/03/2017
Local Ref: 3697

COPE 2

The COPE study was set up in March 2020. The purpose was to rapidly gather information about patients, like you, who were admitted to hospital during the peak of the COVID-19 pandemic. At that time there were recommendations about the assessments and care received when they were admitted to hospital.

One of these assessments is called the Clinical Frailty Scale (CFS). This scale lets the doctors and nurses who looked after you know how fit they were at home in the 2 weeks leading up to their hospital admission. In the UK, all adult patients admitted to hospital with a suspected diagnosis of COVID-19 had this assessment done. It is routinely collected information for everyone.

We would now like to follow up all patients and see what their frailty score is now. We think it is important to know the impact of COVID-19, between 6 and 12 months after hospital admission. It will help the medical community better understand the impact of this illness and provide required support if our findings show higher than expected decline in fitness in those who had COVID-19.

Project Details
Principal Investigator: Ms Kathryn McCarthy
Study Completion: 01/04/2021
Local Ref: 4958

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About Research & Innovation

NBT Researcher

Find out more about our research and how we're working to improve patient care.

Contact Research & Innovation

Research & Innovation
North Bristol NHS Trust
Floor 3, Learning & Research Centre
Southmead Hospital
Westbury-on-Trym
Bristol, BS10 5NB

Telephone: 0117 4149330
Email: research@nbt.nhs.uk