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| Name | Class |
|---|---|
| Sykehuset Ostfold | OTHER |
| University Hospital, Akershus | OTHER |
| Vestre Viken Hospital Trust | OTHER |
| Sykehuset Telemark Hospital Trust |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy | Active Comparator | Colonoscopy surveillance after polyp removal |
|
| Fecal blood testing | Experimental | Fecal testing as surveillance after polypectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal occult blood testing | Diagnostic Test | Fecal testing for blood as surveillance efter polyp removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal cancer incidence | 12 years from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Colorctal cancer mortality | 12 years from randomization | |
| Advanced neoplasia incidence | Findings of colorectal cancer and high-risk polyps | 3 years from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Øyvind Holme | Contact | 004738073000 | oyvind.holme@sshf.no | |
| Michael Bretthauer | Contact | 004790132480 | michael.bretthauer@medisin.uio.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sørlandet sykehus HF | Recruiting | Arendal | Agder | 4838 | Norway |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| UNKNOWN |
| Helse Møre og Romsdal HF | OTHER_GOV |
| St. Olavs Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Sykehuset i Vestfold HF | OTHER |
| Helse Stavanger HF | OTHER_GOV |
| Turku University Hospital | OTHER_GOV |
| Helsinki University Central Hospital | OTHER |
| Randers Regional Hospital | OTHER |
| Viborg Regional Hospital | OTHER |
| Gødstrup Hospital | OTHER |
| Horsens Hospital | OTHER |
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| Colonoscopy | Diagnostic Test | Colonoscopy after polyp removal according to guidelines |
|
| Findings at colonoscopy | Pathology detected during colonoscopy in both arms | 12 years from randomization |
| Colonoscopy utilization | Number of colonoscopies performed | 12 years after randomization |
| Adherence | 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. | 12 years from randomization |
| Cost-effectiveness | 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. | 12 years from randomization |
| Adverse events | Adverse events after colonoscopy | 30 days after colonoscopy |
| Carbon footprint | 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 | 12 years after randomization |
| FIT accuracy | Sensitivity, specificity, postive predictive value and negative predicitive value for colorectal cancer and advanced neoplasia at different FIT-thresholds | 3 years after randomization |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |