title: Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study).
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
  Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma > or = 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.
  
  
  CONCLUSIONS
  The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas.
  
  
  BACKGROUND
  (trialregister.nl) NTR1422.
authors.affiliation: Dept of Gastroenterology & Hepatology, Academic Medical Centre, Amsterdam, The Netherlands. f.j.vandenbroek@amc.uva.nl;
authors.forename: Frank J C
authors.initials: FJ
authors.lastname: van den Broek
authors.forename: Eelco J R
authors.initials: EJ
authors.lastname: de Graaf
authors.forename: Marcel G W
authors.initials: MG
authors.lastname: Dijkgraaf
authors.forename: Johannes B
authors.initials: JB
authors.lastname: Reitsma
authors.forename: Jelle
authors.initials: J
authors.lastname: Haringsma
authors.forename: Robin
authors.initials: R
authors.lastname: Timmer
authors.forename: Bas L A M
authors.initials: BL
authors.lastname: Weusten
authors.forename: Michael F
authors.initials: MF
authors.lastname: Gerhards
authors.forename: Esther C J
authors.initials: EC
authors.lastname: Consten
authors.forename: Matthijs P
authors.initials: MP
authors.lastname: Schwartz
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Boom
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Derksen
authors.forename: A Bart
authors.initials: AB
authors.lastname: Bijnen
authors.forename: Paul H P
authors.initials: PH
authors.lastname: Davids
authors.forename: Christiaan
authors.initials: C
authors.lastname: Hoff
authors.forename: Hendrik M
authors.initials: HM
authors.lastname: van Dullemen
authors.forename: G Dimitri N
authors.initials: GD
authors.lastname: Heine
authors.forename: Klaas
authors.initials: K
authors.lastname: van der Linde
authors.forename: Jeroen M
authors.initials: JM
authors.lastname: Jansen
authors.forename: Rosalie C H
authors.initials: RC
authors.lastname: Mallant-Hent
authors.forename: Ronald
authors.initials: R
authors.lastname: Breumelhof
authors.forename: Han
authors.initials: H
authors.lastname: Geldof
authors.forename: James C H
authors.initials: JC
authors.lastname: Hardwick
authors.forename: Pascal G
authors.initials: PG
authors.lastname: Doornebosch
authors.forename: Annekatrien C T M
authors.initials: AC
authors.lastname: Depla
authors.forename: Miranda F
authors.initials: MF
authors.lastname: Ernst
authors.forename: Ivo P
authors.initials: IP
authors.lastname: van Munster
authors.forename: Ignace H J T
authors.initials: IH
authors.lastname: de Hingh
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Schoon
authors.forename: Willem A
authors.initials: WA
authors.lastname: Bemelman
authors.forename: Paul
authors.initials: P
authors.lastname: Fockens
authors.forename: Evelien
authors.initials: E
authors.lastname: Dekker
mesh_terms: D000236:Adenoma / Q000601:surgery*; D001003:Anal Canal; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D004724:Endoscopy / Q000191:economics*; D006801:Humans; D007413:Intestinal Mucosa / Q000601:surgery; D008866:Microsurgery; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012004:Rectal Neoplasms / Q000601:surgery*; D016896:Treatment Outcome