TY - JOUR
T1 - Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study)
AU - Barendse, Renée M.
AU - Musters, Gijsbert D.
AU - De Graaf, Eelco J.R.
AU - Consten, Esther C.J.
AU - Doornebosch, Pascal G.
AU - Hardwick, James C.
AU - De Hingh, Ignace H.J.T.
AU - Hoff, Chrisiaan
AU - Jansen, Jeroen M.
AU - Van Milligen De Wit, A. W.Marc
AU - Van Der Schelling, George P.
AU - Schoon, Erik J.
AU - Schwartz, Matthijs P.
AU - Weusten, Bas L.A.M.
AU - Dijkgraaf, Marcel G.
AU - Fockens, Paul
AU - Bemelman, Willem A.
AU - Dekker, Evelien
PY - 2018/5/1
Y1 - 2018/5/1
N2 - 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.
AB - 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.
KW - cost-effectiveness
KW - endoscopic mucosal resection
KW - rectal adenoma
KW - transanal endoscopic microsurgery
UR - http://www.scopus.com/inward/record.url?scp=85026665792&partnerID=8YFLogxK
U2 - 10.1136/gutjnl-2016-313101
DO - 10.1136/gutjnl-2016-313101
M3 - Article
C2 - 28659349
AN - SCOPUS:85026665792
SN - 0017-5749
VL - 67
SP - 837
EP - 846
JO - Gut
JF - Gut
IS - 5
ER -