Using faecal tests to follow up on diverticulitis
Use of Faecal Biomarkers After Acute Diverticulitis: Can They Risk Stratify for Colorectal Cancer?
Royal Surrey County Hospital NHS Foundation Trust · NCT06210724
This study is testing if stool tests for hidden blood and inflammation can be a simpler way to follow up with patients who have had diverticulitis instead of using colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 275 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Surrey County Hospital NHS Foundation Trust (other) |
| Locations | 1 site (Guildford, Surrey) |
| Trial ID | NCT06210724 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate whether faecal samples tested for hidden blood and inflammation can serve as an alternative to traditional follow-up procedures like colonoscopy for patients diagnosed with acute diverticulitis. The study will analyze faecal immunochemical tests for haemoglobin (FIT) and faecal calprotectin, alongside assessing the faecal microbiome. By determining the effectiveness of these tests, the researchers hope to improve risk stratification for colorectal cancer and other colonic findings in affected patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with acute diverticulitis via CT scan and require follow-up investigations.
Not a fit: Patients currently being treated for colorectal cancer or those who have undergone significant bowel surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive follow-up procedures in patients with diverticulitis.
How similar studies have performed: While the use of faecal tests in this context is innovative, similar studies have shown promise in utilizing non-invasive methods for colorectal cancer screening.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Computerised tomography diagnosis of acute diverticulitis * Participants capable of giving informed consent * Aged ≥ 18 years * Clinical decision for colonoscopy, flexible sigmoidoscopy or CT colonoscopy follow-up after diverticulitis diagnosis Exclusion Criteria: * Paediatric patients (\<18 years) * Not provided at least 1 faecal 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 * Currently being treated for colorectal cancer * Mental health illness limiting compliance * Treated in hospital with colonic resection * Did not have colonoscopy, flexible sigmoidoscopy or CT colonoscopy
Where this trial is running
Guildford, Surrey
- Royal Surrey County Hospital — Guildford, Surrey, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: James Norman, BMBS, MRCP — Royal Surrey NHS foundation trust
- Study coordinator: James Norman, BMBS, MRCP
- Email: j.norman1@nhs.net
- Phone: +44 (0) 1483 688691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diverticulitis, Colorectal Cancer, Faecal Immunochemical test for haemoglobin, FIT, Faecal calprotectin, Faecal microbiome