Abstract
BackgroundRecent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.Methods/designMulticenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma ≥ 3 cm, located between 1–15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment.Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures.Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group.DiscussionThe TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas.Trial registration number(trialregister.nl) NTR1422
Highlights
Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM)
Rectal cancer accounts for approximately 40% of those Colorectal cancer (CRC) cases
Since early detection and removal of rectal adenomas prevents the occurrence of rectal cancer, CRC screening has been adopted in many western countries[69]
Summary
Rectal cancer is a common disease in the Netherlands with approximately 4,000 new cases and 2,000 deaths annually[1]. In 1984 a novel surgical approach for the resection of large rectal adenomas has been introduced in Germany: transanal endoscopic microsurgery (TEM)[10] This procedure encompasses general anesthesia, the use of expensive specialized equipment, a full-thickness rectal wall excision and hospital admission[11,12]. The literature suggests that EMR is associated with fewer complications, reduced hospital admission, and no general anesthesia is required for EMR, all of which are favorable in both patients' and societal perspective. These contrasts of the two procedures might well lead to differences in costs and quality of life. The main objective of this study will be a cost-effectiveness and cost-utility analysis of these two procedures
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