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

NCT ID: NCT06983639

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-09
• Study Completion Date: 2050-01-01

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.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Colonoscopy

Colonoscopy surveillance after polyp removal

Group Type: ACTIVE_COMPARATOR

Colonoscopy

Intervention Type: DIAGNOSTIC_TEST

Colonoscopy after polyp removal according to guidelines

Fecal blood testing

Fecal testing as surveillance after polypectomy

Group Type: EXPERIMENTAL

Fecal occult blood testing

Intervention Type: DIAGNOSTIC_TEST

Fecal testing for blood as surveillance efter polyp removal

Interventions

Fecal occult blood testing

Fecal testing for blood as surveillance efter polyp removal

Intervention Type: DIAGNOSTIC_TEST

Colonoscopy

Colonoscopy after polyp removal according to guidelines

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sykehuset Ostfold

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

Sykehuset Telemark Hospital Trust

UNKNOWN

Sponsor Role: collaborator

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

University Hospital of Northern Norway, Tromsø, Norway

UNKNOWN

Sponsor Role: collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Randers Regional Hospital

OTHER

Sponsor Role: collaborator

Viborg Regional Hospital

OTHER

Sponsor Role: collaborator

Gødstrup Hospital

OTHER

Sponsor Role: collaborator

Horsens Hospital

OTHER

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sørlandet sykehus HF

Arendal, Agder, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Øyvind Holme

Role: CONTACT

oyvind.holme@sshf.no

004738073000

Michael Bretthauer

Role: CONTACT

michael.bretthauer@medisin.uio.no

004790132480

Facility Contacts

Chief of gastroenterology, MD

Role: primary

johan.christian.holck-steen@sshf.no

004792660445

Other Identifiers

744836

Identifier Type: -

Identifier Source: org_study_id