Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance

Not Applicable

Not yet recruiting

• Conditions: Colorectal Neoplasms

• Registration Number: NCT06983639
• Lead Sponsor: Sorlandet Hospital HF

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-11-01
• Primary Completion: 2040-12-31
• Study Completion: 2050-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Colorectal cancer incidence	12 years from randomization

Secondary Outcome Measures

Name	Time	Method
Colorctal cancer mortality	12 years from randomization
Advanced neoplasia incidence	3 years from randomization	Findings of colorectal cancer and high-risk polyps
Findings at colonoscopy	12 years from randomization	Pathology detected during colonoscopy in both arms
Colonoscopy utilization	12 years after randomization	Number of colonoscopies performed
Adherence	12 years from randomization	Adherence with colonoscopy and FIT surveillance recommendations. Proportion of participants in each arm who are invited for colonoscopy or FIT surveillance and who actually adheres submit the FIT/undergo colonoscopy.
Cost-effectiveness	12 years from randomization	Total cost for FIT-surveillance and colonoscopy surveillance will be calculated and compared, including reimbursement (FIT, colonoscopy, pathology assessment), payment from patients, travel, absenteism from work, cost of complications etc.
Adverse events	30 days after colonoscopy	Adverse events after colonoscopy
Carbon footprint	12 years after randomization	The carbon footprint in each arm will be calculated and compared. Carbon footprint is the total carbon emission from manufacturing, shipping, use, prosessing, litter-handling etc
FIT accuracy	3 years after randomization	Sensitivity, specificity, postive predictive value and negative predicitive value for colorectal cancer and advanced neoplasia at different FIT-thresholds