Objective Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas.
Design Patients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital.
Results Two hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached. The numbers of recurrence-free days alive and out of hospital were similar (EMR 609±209, TEM 652±188, p=0.16). Complications occurred in 18% (EMR) versus 26% (TEM) (p=0.23), with major complications occurring in 1% (EMR) versus 8% (TEM) (p=0.064). Quality-adjusted life years were equal in both groups. EMR was approximately €3000 cheaper and therefore more cost-effective.
Conclusion Under the statistical assumptions of this study, non-inferiority of EMR could not be demonstrated. However, EMR may have potential as the primary method of choice due to a tendency of lower complication rates and a better cost-effectiveness ratio. The high rate of unexpected cancers should be dealt with in further studies.
- rectal adenoma
- endoscopic mucosal resection
- transanal endoscopic microsurgery
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Contributors Study design: FJCvdB, EJRdG, MGD, PF, WAB, ED. Data collection: RMB, GDM, FJCvdB. Data analysis: RMB, GDM, MGD. Data interpretation: RMB, GDM, EJRdG, FJCvdB, ECJC, PGD, JCH, IHJTdH, CH, JMJ, AWMvMdW, GPvdS, EJS, MPS, BLAMW, MGD, PF, WAB, ED. First draft of the manuscript: RMB, with input from GDM, EJRdG, MGD, PF, WAB, ED. Critical revisal of the manuscript: GDM, EJRdG, FJCvdB, ECJC, PGD, JCH, IHJTdH, CH, JMJ, AWMvMdW, GPvdS, EJS, MPS, BLAMW, MGD, PF, WAB, ED. Final approval of the manuscript: RMB, GDM, EJRdG, FJCvdB, ECJC, PGD, JCH, IHJTdH, CH, JMJ, AWMvMdW, GPvdS, EJS, MPS, BLAMW, MGD, PF, WAB, ED.
Funding The trial was sponsored by the Netherlands Organization for Health Research and Development (ZonMw, file number 17092201), which did not have access to outcome data during the trial and did not participate in data analyses or the preparation of the manuscript. No endoscopic or surgical equipment was donated by the manufacturer.
Competing interests Dr. Dijkgraaf reports grants from The Netherlands Organisation for Health Research and Development, during the conduct of the study. Dr. Fockens reports personal fees from Covidien, personal fees from Fujifilm, personal fees from Olympus, outside the submitted work. Dr. Jansen reports personal fees from MSD, personal fees from Abbvie, personal fees from Takeda and personal fees from Hospira, outside the submitted work. Dr. Schoon reports personal fees from Boston-Scientific, personal fees from Medtronic, personal fees from Olympus, outside the submitted work. Furthermore, we declare no competing interests.
Patient consent Detail has been removed from these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.
Ethics approval Institutional Review Board at each study centre.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators The authors thank Bart Bijnen, Dept of Surgery, Medical Center Alkmaar, Alkmaar, The Netherlands; Raf Bisschops, Dept of Gastroenterology, University Hospital Leuven, Leuven, Belgium; Paul Davids, Dept of Surgery, Diakonessenhuis, Utrecht, The Netherlands; Annekatrien Depla, Dept of Gastroenterology, Slotervaart Hospital, Amsterdam, The Netherlands; Hendrik van Dullemen, Dept of Gastroenterology, University Medical CenterGroningen, Groningen, the Netherlands; Michael F Gerhards, Dept of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands; Martin Houben, Dept of Gastroenterology, Haga Teaching Hospital, the Hague, The Netherlands; Klaas vander Linde, Dept of Gastroenterology, Medical Center Leeuwarden, Leeuwarden, The Netherlands; Rosalie Mallant, Dept of Gastroenterology, Flevo Hospital, Almere, The Netherlands; Robin Timmer, Dept of Gastroenterology, St Antonius Hospital, Nieuwegein, The Netherlands; Ben Witteman, Dept of Gastroenterology, GelderseVallei Hospital, Ede, The Netherlands; Albert Wolthuis, Dept of Surgery, University Hospital Leuven, Leuven, Belgium.
Correction notice This article has been corrected since it published Online First. The acknowledgements and collaborators statements have been updated.