Clinical trial NCT06983639: Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance
Official title: FIT Versus Colonoscopy for Post-polypectomy Surveillance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: surveillance
polyp
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Sykehuset Ostfold
name: University Hospital, Akershus
name: Vestre Viken Hospital Trust
name: Sykehuset Telemark Hospital Trust
name: Helse Møre og Romsdal HF
name: St. Olavs Hospital
name: University Hospital of Northern Norway, Tromsø, Norway
name: Sykehuset i Vestfold HF
name: Helse Stavanger HF
name: Turku University Hospital
name: Helsinki University Central Hospital
name: Randers Regional Hospital
name: Viborg Regional Hospital
name: Gødstrup Hospital
name: Horsens Hospital
First posted: 2025-05-21
Enrollment: 4000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Colorectal cancer is the third most common cancer in the world and develops from benign colorectal polyps. Colonoscopy with polyp removal reduces colorectal cancer incidence and mortality. Patients who have had polyps removed are at increased risk for metachronous polyps and subsequent cancer and are referred to colonoscopic surveillance at regular intervals, the first one usually scheduled three years after polypectomy. Today, these comprise 15-25% of all colonoscopies, but in \>85%, no high-risk pathology is found. Thus, post-polypectomy surveillance consumes major resources without benefit to the patients, and these resources are much needed for colonoscopies due to other indications in an aging population. Additionally, colonoscopy requires burdensome bowel-cleansing, discomfort during the examination, absenteeism from work and sometimes need for an escort. Severe complications like bleeding and perforation may occur. Overdiagnosis and overtreatment of benign lesions occur in a large proportion of examinations as most polyps will never develop into colorectal cancer, even if left untreated.

Sensitive fecal occult blood tests (FIT) have been developed that may detect colorectal cancer with the same sensitivity as colonoscopy. The test is cheap, is easily distributed by mail and may be performed at home. If the test detects blood, colonoscopy is indicated. FIT has been used in colorectal screening program for years, but has not yet been thoroughly investigated for post-polypectomy surveillance purposes.

The trial is a pragmatic non-inferiority randomized trial in which patients who are eligible for 3-year colonoscopic surveillance are offered either colonoscopy (standard care) or FIT followed by a colonoscopy in case of a positive test result (Figure 1). FIT may decrease colonoscopy surveillance demand by \> 50%, which equals a cost saving of almost 30,000,000 Norwegian kroner annually. By proposing FIT for post-polypectomy surveillance, the trial introduce decentralized and personalized medical follow-up of these patients, and at the same time reduce work-absenteeism, patient discomfort, risk of complications and importantly: overdiagnosis and overtreatment of benign colorectal lesions.

Eligibility 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

Primary outcomes:
measure: Colorectal cancer incidence
timeFrame: 12 years from randomization
Secondary outcomes:
measure: Colorctal cancer mortality
timeFrame: 12 years from randomization
measure: Advanced neoplasia incidence
timeFrame: 3 years from randomization
measure: Findings at colonoscopy
timeFrame: 12 years from randomization
measure: Colonoscopy utilization
timeFrame: 12 years after randomization
measure: Adherence
timeFrame: 12 years from randomization
measure: Cost-effectiveness
timeFrame: 12 years from randomization
measure: Adverse events
timeFrame: 30 days after colonoscopy
measure: Carbon footprint
timeFrame: 12 years after randomization
measure: FIT accuracy
timeFrame: 3 years after randomization
Other outcomes:
Locations:
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