An observational study in Diverticulitis and Colorectal Cancer, sponsored by Royal Surrey County Hospital NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Royal Surrey County Hospital NHS Foundation Trust · Observational
Background and study aims
Diverticular disease or diverticulosis is a benign disease of the colon. Diverticulae are pockets of bowel wall which protrude through weaknesses in the muscular wall of the colon. The mechanisms leading to their formation remains unclear and is likely a complex interaction of multiple factors. For the majority of people these pockets are incidental findings they can become inflamed which is called diverticulitis.
The main aim of this study is to see if a faecal samples, which will be tested for hidden blood content with a faecal immunochemical test for haemoglobin (FIT), could be used as an alternative to currently used follow-up investigations for patients who have an episode of acute diverticulitis confirmed on a computerised tomography (CT) scan. These are colonoscopy, sigmoidoscopy or a special CT called CT colonoscopy.
The investigators will also be testing faecal calprotectin which is a marker of bowel inflammation and an assessment of the microbes that live in the bowel to see if this will provide further insights into the diagnosis and treatment of diverticulitis.
Who can participate?
All patients 18 or over admitted to a participating hospital with acute diverticulitis confirmed on a CT scan and who planned to have one of the currently used follow-up investigations are eligible.
What does the study involve?
The study will involve participants taking three stool (faecal) samples using faecal testing kits posted to participants. One is as close to their first solid stool after diagnosis as possible, the others are at 3 weeks after diagnosis and then 6 weeks after diagnosis.
What are the possible benefits and risks of participating?
There are no risks of participating. The investigators hope to demonstrate that a negative FIT test for patients after acute diverticulitis will be able to exclude a bowel cancer and prevent the majority of future patients having invasive and time consuming tests. There no additional benefit for participants for their current episode, as they will still need to have these tests.
Where is the study run from?
Royal Surrey County Hospital
When is the study starting and how long is it expected to run for?
09/10/2023-30/09/2024
Who is funding the study?
The study is being funded by MATTU (Minimal Access Therapy Training Unit), GUTS (GUTS - Fighting Bowel Cancer) and NHIR (National Institute for Health and Care Research).
Who is the main contact?
James Norman, On the study email rsch.colorectalDfitstudy@nhs.net
What is the purpose of the study?
The main aim of this study is to see if a faecal immunochemical test (FIT), could be used as an alternative to currently used follow-up investigations, of colonoscopy, flexible sigmoidoscopy or CT (computerised tomography) colonography, for patients who have an episode of acute diverticulitis to exclude a colorectal cancer (CRC). As stated in the ASCPGBI consensus guidelines 2021 the risk of CRC in those with CT diagnosed uncomplicated diverticulitis is 1.6-1.9% and in those with complicated diverticulitis 7.8-10.9%.
Our primary aim is to determine whether single, or multiple faecal haemoglobin and faecal calprotectin results after an episode of acute diverticulitis can be used to risk stratify for further investigations to exclude colorectal cancer.
Our secondary aims are:
To determine whether single, or multiple faecal haemoglobin and faecal calprotectin results after an episode of acute diverticulitis could be used to risk stratify for further investigations to exclude other colonic findings such as high-risk adenoma?
Would including demographic factors such as age or anaemia allow better risk stratification?
Assess the faecal microbiome in patients with acute diverticulitis and how it changes as inflammation settles.
Any antibiotic treatment will also be recorded and the effect on the faecal microbiome analysed.
Inclusion criteria:
Computerised tomography diagnosis of acute diverticulitis Participants capable of giving informed consent Aged ≥ 18 years Planned for colonoscopy, flexible sigmoidoscopy or CT colonoscopy after diverticulitis diagnosis
Exclusion criteria:
Paediatric patients (\<18 years) Not provided at least 1 FIT sample Unable to/unwilling to provide informed consent Withdrawal of consent for inclusion in study Previous pan-proctocolectomy, subtotal colectomy surgery, or presence of stoma Diagnosed with colorectal cancer Mental health illness limiting compliance Treated in hospital with colonic resection Did not have colonoscopy, flexible sigmoidoscopy or CT colonoscopy
Recruitment:
Patients who attend hospital with a diagnosis of acute diverticulitis confirmed on a CT scan and who have had a clinical decision to follow-up with either a colonoscopy, flexible sigmoidoscopy or CT colonography will be approached for written consent to participate.
Patients will then be posted a patient information leaflet and a pack with collection devices to take samples at home and post back. The results of their follow-up investigation (colonoscopy, flexible sigmoidoscopy or CT colonography + any histology) will be collected when completed
Involvement for patients will involve collecting and posting back in pre-paid envelopes faecal samples on their first solid stool (or as soon as possible after diagnosis) and at 3 and 6 weeks post-diagnosis.
Sample size: 275 - Estimated using available data on diverticulitis and stratified data from FIT use in 2WW patients.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's planned enrollment of 275 is close to the median of 275 across 59 observational studies indexed under Diverticulitis.
Browse Diverticulitis studies →Royal Surrey County Hospital NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients attending hospital with a radiological diagnosis of acute diverticulitis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to standard of care, three faecal samples will be obtained. On as soon as possible after diagnosis, one at three weeks post diagnosis and one at six.
Diagnostic Test: Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiome
Faecal samples to be collected by patients at home and delivered via post to a bowel cancer screening hub for analysis
Colorectal Cancer
Diagnosis or absence of colorectal cancer on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Time frame: Dependant on timing of investigation but expected 6-12 weeks
High risk adenoma
Diagnosis or absence of high risk adenoma on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Diverticulitis
Diagnosis or absence of ongoing diverticular inflammation on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Perianal disease
Diagnosis or absence of perianal disease on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Inflammatory bowel disease
Diagnosis or absence of inflammatory bowel disease on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Microscopic colitis
Diagnosis or absence of microscopic colitis on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Time frame: Dependant on timing of investigation but expected 6-12 weeks
FIT (Faecal Immunochemical Test for haemoglobin) test result
Results of the three FIT tests taken by the participant, ≥ 10 defined as FIT positive
Time frame: 6 weeks
Faecal calprotectin test result
Results of the three faecal calprotectin tests taken by the participant, ≥ 50 defined as positive
Time frame: 6 weeks
Faecal microbiome
Results of the microbiome run on the three faecal samples taken by the participant
Time frame: 6 weeks
Blood tests
Haemoglobin and mean cell volume from routine blood tests when patient attended
Time frame: Will happen before CT diagnosing diverticulitis
Plan to share: No — All data will be anonymised before analysis and before any data is shared with other researchers
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Sep 2024, 11 months after the start.
Of 22 observational studies under Diverticulitis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 101. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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Royal Surrey County Hospital NHS Foundation Trust