Journal Article

Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study)

Consten, Esther C J, van der Schelling, George P, Dijkgraaf, Marcel G, de Hingh, Ignace H J T, Schwartz, Matthijs P, van Milligen de Wit, A W Marc, van den Broek, Frank J C, Bemelman, Willem A, Hoff, Chrisiaan, Dekker, Evelien, Doornebosch, Pascal G, Hardwick, James C, Jansen, Jeroen M, Schoon, Erik J, Weusten, Bas L A M, Fockens, Paul, Barendse, Renée M, Musters, Gijsbert D, de Graaf, Eelco J R

2018

Overview

ObjectiveNon-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.DesignPatients 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.ResultsTwo 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.ConclusionUnder 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.

• Publisher: BMJ Publishing Group LTD
• Subject: Adenoma / Adenoma - pathology / Adenoma - surgery / Aged / Anesthesia / Belgium / Cancer / Cost-Benefit Analysis / Dissection / Endoscopic Mucosal Resection - adverse effects / Endoscopic Mucosal Resection - economics / Endoscopic Mucosal Resection - methods / Endoscopy / Fecal incontinence / Female / Follow-Up Studies / Humans / Male / Medical screening / Microsurgery / Middle Aged / Morbidity / Mucosa / Neoplasm Recurrence, Local / Netherlands / Patients / Precancerous Conditions - surgery / Quality of Life / Rectal Neoplasms - pathology / Rectal Neoplasms - surgery / Rectum / Statistics / Studies / Surgical outcomes / Systematic review / Transanal Endoscopic Microsurgery - adverse effects / Transanal Endoscopic Microsurgery - economics / Transanal Endoscopic Microsurgery - methods / Treatment Outcome / Tumors