Colorectal Completed Research

Up to 40% of patients who develop colorectal cancer are either not fit enough for resectional surgery or have advanced disease. Treatment in these patients is palliative and aimed at prolonging life and maximising its quality.

A significant proportion of patients with colorectal cancer present as an emergency, where the cancer has caused a bowel blockage. Unless the blockage is relieved, the bowel perforates and the patient develops peritonitis. Surgery, if performed, is associated with increased mortality, prolonged hospital stay, increased stoma formation, reduced quality of life and patients are often unable to have chemotherapy.

An alternative to surgery for patients presenting with an obstruction is stent insertion across the blocked part of the bowel. The stent is made of a special metal which expands when inserted. The procedure does not require general anaesthetic, and when successful, provides immediate relief of symptoms, avoiding the need for surgery and a stoma.

When a stent is inserted into patients who are too unfit for major surgery or the cancer is too advanced for surgery, the stent is left in the patient indefinitely. Survival in these palliative patients is improving and about half the patients receiving chemotherapy will survive 18-24 months. Unfortunately, stent related complications are common, occurring in over one third of patients. Potential complications include bowel perforation, stent obstruction with recurrent blockage and stent migration. Two designs of stent are used in the UK; uncovered stents made of bare metal, and stents with a plastic covering designed to reduce the chances of stent blockage.

Currently there is insufficient information comparing the two stent designs in terms of relative risk of complications of each stent design and outcome related to patient's expectations and quality of life.

CReST2 will assess whether uncovered or covered stents are best for patients treated for palliation.

Project Details
Principal Investigator: Miss Anne Pullyblank

Study Completion: 30/04/2023
Local Ref: 3985

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

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

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

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

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

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 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

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

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

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

Volatile Organic compounds for detection of colorectal cancer or the VODECA study is a case control study that aims to investigate volatile organic compounds (VOCs) associated with adenomas and early colorectal cancer (CRC) ultimately developing a panel of VOCs that can be used to select patients for colonoscopy to improve detection of colorectal neoplasia and reduce deaths from colon cancer.

Project Details
Principal Investigator: Miss Anne Pullybank

Study Completion: 30/04/2022

Local Ref: 4586

The aim of this study is to understand patients’ and healthcare professionals’ views towards real time monitoring of patients’ experiences using ePROMs. This information will be used to optimise the impact of a quality improvement programme and improve the pathway of care at an NHS trust. Specifically, the study will explore:

• The acceptability of automated, real-time monitoring of patients’ experience.
• The impact of monitoring on clinical care.

This study will conduct semi-structured in-depth interviews and observations with patients and healthcare professionals to support a quality improvement programme at an NHS Trust.

Shared decision-making is when patients and healthcare professionals, such as doctors, make treatment decisions together. Southmead Hospital is testing ways to improve shared decision-making processes for patients. As part of this, you will have completed a short questionnaire about your experience with shared decision making during your consultation

discussions. This study wants to find out how you felt about sharing your views in this way by interviewing you. We would also like to audio-record consultations to understand whether communication between patients and healthcare professionals has improved.

This helps everyone understand what has worked well, as well as highlighting where improvements need to be made. The overall aim is to help improve the communication between patients and doctors and make the shared decision-making process better for everyone.

Project Details
Principal Investigator: Mr Angus McNair
Study Completion: 04/2023
Local Ref: 5022