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Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study) |
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| Authors: | Frank JC van den Broek Eelco JR de Graaf Marcel GW Dijkgraaf Johannes B Reitsma Jelle Haringsma Robin Timmer Bas LAM Weusten Michael F Gerhards Esther CJ Consten Matthijs P Schwartz Maarten J Boom Erik J Derksen A Bart Bijnen Paul HP Davids Christiaan Hoff Hendrik M van Dullemen G Dimitri N Heine Klaas van der Linde Jeroen M Jansen Rosalie CH Mallant-Hent Ronald Breumelhof Han Geldof James CH Hardwick Pascal G Doornebosch Annekatrien CTM Depla Miranda F Ernst Ivo P van Munster Ignace HJT de Hingh Erik J Schoon Willem A Bemelman Paul Fockens Evelien Dekker |
| Institution: | 1. Dept of Gastroenterology & Hepatology, Academic Medical Centre, Amsterdam, The Netherlands 2. Dept of Surgery, IJsselland Hospital, Capelle aan de IJssel, The Netherlands 3. Dept of Clinical Epidemiology, Biostatistics and bioinformatics, Academic Medical Centre, Amsterdam, The Netherlands 4. Dept of Gastroenterology, Erasmus Medical Centre, Rotterdam, The Netherlands 5. Dept of Gastroenterology, St Antonius Hospital, Nieuwegein, The Netherlands 6. Dept of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands 7. Dept of Surgery, Meander Medical Centre, Amersfoort, the Neterhlands 8. Dept of Gastroenterology, Meander Medical Centre, Amersfoort, the Neterhlands 9. Dept of Surgery, Flevoziekenhuis, Almere, The Netherlands 10. Dept of Surgery, Slotervaart Hospital, Amsterdam, The Netherlands 11. Dept of Surgery, Medical Centre Alkmaar, Alkmaar, The Netherlands 12. Dept of Surgery, Diakonessenhuis, Utrecht, The Netherlands 13. Dept of Surgery, Medical Centre Leeuwarden, Leeuwarden, The Netherlands 14. Dept of Gastroenterology, University Medical Centre, Groningen, The Netherlands 15. Dept of Gastroenterology, Medical Centre Alkmaar, Alkmaar, The Netherlands 16. Dept of Gastroenterology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands 17. Dept of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands 18. Dept of Gastroenterology, Flevoziekenhuis, Almere, The Netherlands 19. Dept of Gastroenterology, Diakonessenhuis, Utrecht, The Netherlands 20. Dept of Gastroenterology, IJsselland Hospital, Capelle aan de IJssel, The Netherlands 21. Dept of Gastroenterology, Leiden University Medical Centre, Leiden, The Netherlands 22. Dept of Surgery, IJsselland Hospital, Capelle aan de IJssel, The Netherlands 23. Dept of Gastroenterology, Slotervaart Hospital, Amsterdam, The Netherlands 24. Dept of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands 25. Dept of Gastroenterology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands 26. Dept of Surgery, Catharina Hospital, Eindhoven, The Netherlands 27. Dept of Gastroenterology, Catharina Hospital, Eindhoven, The Netherlands 28. Dept of Surgery, Academic Medical Centre, Amsterdam, The Netherlands |
| 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 |
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