Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study)

Frank J C van den Broek, Eelco J R de Graaf, Marcel G W Dijkgraaf, Johannes B Reitsma, Jelle Haringsma, Robin Timmer, Bas L A M Weusten, Michael F Gerhards, Esther C J Consten, Matthijs P Schwartz, Maarten J Boom, Erik J Derksen, A Bart Bijnen, Paul H P Davids, Christiaan Hoff, Hendrik M van Dullemen, G Dimitri N Heine, Klaas van der Linde, Jeroen M Jansen, Rosalie C H Mallant-Hent, Ronald Breumelhof, Han Geldof, James C H Hardwick, Pascal G Doornebosch, Annekatrien C T M Depla, Miranda F Ernst, Ivo P van Munster, Ignace H J T de Hingh, Erik J Schoon, Willem A Bemelman, Paul Fockens, Evelien Dekker, Frank J C van den Broek, Eelco J R de Graaf, Marcel G W Dijkgraaf, Johannes B Reitsma, Jelle Haringsma, Robin Timmer, Bas L A M Weusten, Michael F Gerhards, Esther C J Consten, Matthijs P Schwartz, Maarten J Boom, Erik J Derksen, A Bart Bijnen, Paul H P Davids, Christiaan Hoff, Hendrik M van Dullemen, G Dimitri N Heine, Klaas van der Linde, Jeroen M Jansen, Rosalie C H Mallant-Hent, Ronald Breumelhof, Han Geldof, James C H Hardwick, Pascal G Doornebosch, Annekatrien C T M Depla, Miranda F Ernst, Ivo P van Munster, Ignace H J T de Hingh, Erik J Schoon, Willem A Bemelman, Paul Fockens, Evelien Dekker

Abstract

Background: Recent 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/design: Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma > or = 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.

Discussion: The 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.

Figures

Figure 1
Figure 1
Flow chart of TREND study; 15 Dutch centers will be participating in this multicenter randomized trial (R = randomization).

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