Background: Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal\ncolorectal polyps. However, in large lesions EMR can often only be performed in a piecemeal fashion resulting\nin relatively low radical (R0)-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD)\nis a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the\nhigh en-bloc resection rates and the very low recurrence rates. We aim to evaluate the (cost-)effectiveness\nof ESD against EMR on both short (i.e. 6 months) and long-term (i.e. 36 months). We hypothesize that in the\nshort-run ESD is more time consuming resulting in higher healthcare costs, but is (cost-) effective on the\nlong-term due to lower patients burden, a higher number of R0-resections and lower recurrence rates with\nless need for repeated procedures.\nMethods: This is a multicenter randomized clinical trial in patients with a non-pedunculated polyp larger than\n20 mm in the rectum, sigmoid, or descending colon suspected to be an adenoma by means of endoscopic\nassessment. Primary endpoint is recurrence rate at follow-up colonoscopy at 6 months. Secondary endpoints\nare R0-resection rate, perceived burden and quality of life, healthcare resources utilization and costs, surgical\nreferral rate, complication rate and recurrence rate at 36 months. Quality-adjusted-life-year (QALY) will be estimated\ntaking an area under the curve approach and using EQ-5D-indexes. Healthcare costs will be calculated by multiplying\nused healthcare services with unit prices. The cost-effectiveness of ESD against EMR will be expressed as incremental\ncost-effectiveness ratios (ICER) showing additional costs per recurrence free patient and as ICER showing additional\ncosts per QALY.\nDiscussion: If this trial confirms ESD to be favorable on the long-term, the burden of extra colonoscopies and\nrepeated procedures can be prevented for future patients.
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