Original Primary Outcome:

• Recurrence rate at follow-up colonoscopy after 6 months [ Time Frame: 6 months ]
  Observed from resected residual disease or, if not present, from biopsies of the scar
• Radical (R0-)resection rate [ Time Frame: within 1 month ]
  Defined as dysplasia free vertical and lateral resection margins at histology

Current Secondary Outcome:

• Long-term recurrence rate at follow-up colonoscopy after 36 months [ Time Frame: 36 months ]
  Observed from resected residual disease or, if not present, from biopsies of the scar
• Health care resource utilization and consts [ Time Frame: 36 months ]
  Healthcare costs will be calculated by multiplying used healthcare services with unit prices. The cost-effectiveness of ESD against EMR will be expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per recurrence free patient and as ICER showing additional costs per QALY.
• Perceived burden and quality of life among patients [ Time Frame: 36 months ]
  Measurement of the patients' burden of ESD versus EMR will be evaluated with regard to colorectal cancer anxiety, burden of the procedure itself, functional complaints and overall quality of life. Meaurement will be performed using validated questionnaires.
• Complication rate [ Time Frame: 30 days ]
  Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
• Surgical referral rate [ Time Frame: 36 months ]
  Defined as the number of patients that are referred for surgical management at 36 months
• R0-resection rate [ Time Frame: 30 days ]
  Defined as dysplasia free vertical and lateral resection margins at histology

Original Secondary Outcome:

• Long-term recurrence rate at follow-up colonoscopy after 36 months [ Time Frame: 36 months ]
  Observed from resected residual disease or, if not present, from biopsies of the scar
• Cost-effectiveness at 36 months [ Time Frame: 36 months ]
  Method of assessment: questionnaire. The cost-effectiveness of ESD against EMR will be performed with the costs per recurrence free patient and the cost per quality adjusted life year (QALY) as outcome measures. QALY will be measured using the EuroQol EQ-5D-5L questionairre.
• Perceived burden among patients [ Time Frame: 36 months ]
  Measurement of the patients' burden of ESD versus EMR will be evaluated with regard to colorectal cancer anxiety, burden of the procedure itself, functional complaints and overall quality of life. Meaurement will be performed using validated questionnaires.
• Complication rate [ Time Frame: Within 30 days after endoscopic resection ]
  Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
• Surgical referral rate [ Time Frame: 36 months ]
  Defined as the number of patients that are referred for surgical management at 36 months

Dates:
Date Received: January 8, 2016
Date Started: April 2016
Date Completion: December 2020
Last Updated: October 24, 2016
Last Verified: October 2016