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BMC Surgery
Published in: BMC Surgery 1/2009

Open Access 01-12-2009 | Study protocol

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

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

Published in: BMC Surgery | Issue 1/2009

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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 ≥ 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
Appendix
Available only for authorised users
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Metadata
Title
Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study)
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
Publication date
01-12-2009
Publisher
BioMed Central
Published in
BMC Surgery / Issue 1/2009
Electronic ISSN: 1471-2482
DOI
https://doi.org/10.1186/1471-2482-9-4

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