Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. In large lesions, EMR can often only be performed in a piecemeal fashion resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this into perspective against the costs and complication rates of both strategies and the burden perceived by patients on the long term-term.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
UMC Utrecht
Utrecht, Utrecht, Netherlands
RECRUITINGRecurrence rate at follow-up colonoscopy after 6 months
Observed from resected residual disease or, if not present, from biopsies of the scar
Time frame: 6 months
Long-term recurrence rate at follow-up colonoscopy after 36 months
Observed from resected residual disease or, if not present, from biopsies of the scar
Time frame: 36 months
Health care resource utilization and consts
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.
Time frame: 36 months
Perceived burden and quality of life among patients
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.
Time frame: 36 months
Complication rate
Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
Time frame: 30 days
Surgical referral rate
Defined as the number of patients that are referred for surgical management at 36 months
Time frame: 36 months
R0-resection rate
Defined as dysplasia free vertical and lateral resection margins at histology
Time frame: 30 days
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