Comparing at-home fecal blood testing (FIT) versus colonoscopy after polyp removal
FIT Versus Colonoscopy for Post-polypectomy Surveillance
This will test whether at-home fecal immunochemical tests (FIT) can safely replace routine follow-up colonoscopy for people who have had colorectal polyps removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4000 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Sorlandet Hospital HF Government |
| Locations | 1 site (Arendal, Agder) |
| Trial ID | NCT06983639 on ClinicalTrials.gov |
What this trial studies
This randomized trial compares a surveillance strategy using regular fecal immunochemical testing (FIT) with standard follow-up colonoscopy after removal of colorectal polyps. Eligible participants have had a high-quality baseline colonoscopy with all polyps removed and at least one advanced adenoma resected. Those randomized to FIT will do at-home stool tests and be referred to colonoscopy only if the FIT is positive, while the colonoscopy arm will undergo routine surveillance colonoscopy. Outcomes include detection of advanced neoplasia, colorectal cancer incidence, procedure-related complications, and resource use.
Who should consider this trial
Good fit: Adults who had a high-quality baseline colonoscopy with complete polyp removal and at least one advanced adenoma, who can give informed consent, are the ideal candidates.
Not a fit: People with colorectal cancer, prior colectomy, known hereditary cancer syndromes, inflammatory bowel disease, or very many baseline adenomas (≥10) are excluded and unlikely to benefit from FIT-based surveillance.
Why it matters
Potential benefit: If successful, this approach could substantially reduce the number of surveillance colonoscopies, lowering patient burden and freeing endoscopy resources.
How similar studies have performed: FIT has proven effective in population screening for colorectal cancer, but its use specifically for post-polypectomy surveillance has been less thoroughly tested and lacks large randomized evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * High-quality baseline colonoscopy with adequat cleansing and cecal intubation * Remocval of at least one advanced adenoma * Clean colon (all polyps removed) * Signed informed consent Exclusion Criteria: * Colorectal cancer * History of surgical colon resection for any reason * Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome) * ≥ 10 adenomas at baseline colonoscopy (cumulative) * History of advanced serrated lesion, defined as SSL≥ 10mm or with dysplasia * Inflammatory bowel disease * On-going palliative care for any reason
Where this trial is running
Arendal, Agder
- Sørlandet sykehus HF — Arendal, Agder, Norway (Recruiting)
Study contacts
- Study coordinator: Øyvind Holme
- Email: oyvind.holme@sshf.no
- Phone: 004738073000
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.