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Open Access Highly Accessed Study protocol

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

Frank JC van den Broek1, Eelco JR de Graaf2, Marcel GW Dijkgraaf3, Johannes B Reitsma3, Jelle Haringsma4, Robin Timmer5, Bas LAM Weusten5, Michael F Gerhards6, Esther CJ Consten7, Matthijs P Schwartz8, Maarten J Boom9, Erik J Derksen10, A Bart Bijnen11, Paul HP Davids12, Christiaan Hoff13, Hendrik M van Dullemen14, G Dimitri N Heine15, Klaas van der Linde16, Jeroen M Jansen17, Rosalie CH Mallant-Hent18, Ronald Breumelhof19, Han Geldof20, James CH Hardwick21, Pascal G Doornebosch22, Annekatrien CTM Depla23, Miranda F Ernst24, Ivo P van Munster25, Ignace HJT de Hingh26, Erik J Schoon27, Willem A Bemelman28, Paul Fockens1 and Evelien Dekker1*

Author affiliations

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

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Citation and License

BMC Surgery 2009, 9:4  doi:10.1186/1471-2482-9-4

Published: 13 March 2009

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