Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance
Recruiting · NCT06983639 · Interventional (participants receive a specific treatment) · Lead sponsor: Sorlandet Hospital HF
View the official record on ClinicalTrials.gov →Interventions studied
ColonoscopyFecal occult blood testing
What this trial is about
From observational studies, it is know that the risk of developing colorectal cancer after polyp removal is lower if the patients adheres to surveillance recommendations. However, colonoscopy is burdensome for patients and colonoscopy availability is limited in many parts of the world. In addition, more than half of surveillance colonoscopies are without any findings. The trial investigates whether surveillance using fecal testing for blod is as good as colonoscopy after removal of colorectal polyps.
Who can take part
Age range
40 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Sørlandet sykehus HF - Arendal, Agder, Norway