Methods

JOINT DESIGN SETTING

EPoS I and II are randomised controlled trials. EPoS III is a one-arm observational study. Eligible for all trials are individuals with no history of CRC or adenomas between 40 and 74 years who have undergone colonoscopy with removal of one or more adenomas or serrated polyps at one of the study centres.

Patients can be included at any point in time between the baseline colonoscopy and the date of first surveillance colonoscopy.  

Surveillance colonoscopies


Surveillance colonoscopy is the intervention tool used in all trials. At surveillance colonoscopy, all detected polyps will be registered and described, removed whenever possible and subjected to histopathology. All required data from endoscopy reports, quality-data used for quality monitoring and histopathologic results must be registered in the central study database. Local pathology labs will serve the participating centres and perform histopathological analysis of the tissue samples.

Time of surveillance colonoscopies 


​Surveillance colonoscopies are scheduled at the participating centres according to the time slots defined in the protocol for the different study groups and arms 
Surveillance colonoscopies are to be performed within a 6-month time interval from the protocol-defined date. Surveillance colonoscopies which are performed earlier than 6 months before or later than 6 months after the protocol-defined date are recorded as a protocol deviation.

JOINT INCLUSION CRITERIA FOR ALL EPOS TRIALS


  • Men and women age 40-74 years
  • Cecal intubation (preferably documented by images/video of the appendiceal orifice and the ileocecal valve; but not required).
  • Adequate colonic cleansing, with Boston Bowel Cleansing Score equal or higher than 2 points in all colonic segments.
  • Complete excision of all polyps at baseline colonoscopy findings (as judged by the trial endoscopists)
  • Randomisation must be performed no longer than 26 weeks (182 days) from completion date of baseline colonoscopy 

JOINT EXCLUSION CRITERIA FOR ALL EPOS TRIALS


  • Lack of consent
  • History of CRC or adenomas
  • History of serrated polyps ≥ 10 mm in diameter at any colorectal location or ≥ 5 mm if located proximal to the splenic flexure
  • More than 10 adenomas
  • Incomplete colonoscopy
  • Incomplete endoscopic excision of polyps
  • Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
  • Inflammatory bowel disease
  • History of surgical colon resection for any reason
  • Severe co-morbidity with reduced life expectancy (NYHA 3-4)
  • On-going cytotoxic treatment or radiotherapy for malignant disease
  • Long-lasting attention and nursing services (somatic or psychosocial, mental retardation).