title: The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019).
abstract: BACKGROUND
  Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment.
  
  
  METHODS
  These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm.
  
  
  CONCLUSIONS
  The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course.
  
  
  BACKGROUND
  NTR2883 ; ISRCTN56523019.
authors.affiliation: Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
authors.forename: Tjibbe J
authors.initials: TJ
authors.lastname: Gardenbroek
authors.affiliation: Department of Surgery, University Hospitals Birmingham, Birmingham, UK.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Pinkney
authors.affiliation: Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
authors.forename: Saloomeh
authors.initials: S
authors.lastname: Sahami
authors.affiliation: Department of Surgery, University Hospitals Birmingham, Birmingham, UK.
authors.forename: Dion G
authors.initials: DG
authors.lastname: Morton
authors.affiliation: Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
authors.forename: Christianne J
authors.initials: CJ
authors.lastname: Buskens
authors.affiliation: Department of Gastroenterology, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Cyriel Y
authors.initials: CY
authors.lastname: Ponsioen
authors.affiliation: Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
authors.forename: Pieter J
authors.initials: PJ
authors.lastname: Tanis
authors.affiliation: Department of Gastroenterology, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Mark
authors.initials: M
authors.lastname: Löwenberg
authors.affiliation: Department of Gastroenterology, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Gijs R
authors.initials: GR
authors.lastname: van den Brink
authors.affiliation: Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands.
authors.forename: Ivo Amj
authors.initials: IA
authors.lastname: Broeders
authors.affiliation: Department of Gastroenterology, Meander Medical Center, Amersfoort, The Netherlands.
authors.forename: Paul Hjm
authors.initials: PH
authors.lastname: Pullens
authors.affiliation: Department of Gastroenterology, Amphia Hospital, Breda, The Netherlands.
authors.forename: Tom
authors.initials: T
authors.lastname: Seerden
authors.affiliation: Department of Surgery, Flevo Hospital, Almere, The Netherlands.
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Boom
authors.affiliation: Department of Gastroenterology, Flevo Hospital, Almere, The Netherlands.
authors.forename: Rosalie C
authors.initials: RC
authors.lastname: Mallant-Hent
authors.affiliation: Department of Surgery, Isala Hospital, Zwolle, The Netherlands.
authors.forename: Robert Egjm
authors.initials: RE
authors.lastname: Pierik
authors.affiliation: Department of Gastroenterology, Isala Hospital, Zwolle, The Netherlands.
authors.forename: Juda
authors.initials: J
authors.lastname: Vecht
authors.affiliation: Department of Surgery, Atrium Medical Center, Heerlen, The Netherlands.
authors.forename: Meindert N
authors.initials: MN
authors.lastname: Sosef
authors.affiliation: Department of Gastroenterology, Atrium Medical Center, Heerlen, The Netherlands.
authors.forename: Annick B
authors.initials: AB
authors.lastname: van Nunen
authors.affiliation: Department of Surgery, Lucas Andreas Hospital, Amsterdam, The Netherlands.
authors.forename: Bart A
authors.initials: BA
authors.lastname: van Wagensveld
authors.affiliation: Department of Gastroenterology, Lucas Andreas Hospital, Amsterdam, The Netherlands.
authors.forename: Pieter Cf
authors.initials: PC
authors.lastname: Stokkers
authors.affiliation: Department of Surgery, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Gerhards
authors.affiliation: Department of Gastroenterology, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands.
authors.forename: Jeroen M
authors.initials: JM
authors.lastname: Jansen
authors.affiliation: Department of Surgery, Slotervaart Hospital, Amsterdam, The Netherlands.
authors.forename: Yair
authors.initials: Y
authors.lastname: Acherman
authors.affiliation: Department of Gastroenterology, Slotervaart Hospital, Amsterdam, The Netherlands.
authors.forename: Annekatrien Ctm
authors.initials: AC
authors.lastname: Depla
authors.affiliation: Department of Surgery, St. Franciscus Hospital, Rotterdam, The Netherlands.
authors.forename: Guido Hh
authors.initials: GH
authors.lastname: Mannaerts
authors.affiliation: Department of Gastroenterology, St. Franciscus Hospital, Rotterdam, The Netherlands.
authors.forename: Rachel
authors.initials: R
authors.lastname: West
authors.affiliation: Department of Gastroenterology, University Hospitals Birmingham, Birmingham, UK.
authors.forename: Tariq
authors.initials: T
authors.lastname: Iqbal
authors.affiliation: Department of Gastroenterology, University Hospitals Birmingham, Birmingham, UK.
authors.forename: Shrikanth
authors.initials: S
authors.lastname: Pathmakanthan
authors.affiliation: Birmingham Clinical Trials Unit, University Hospitals Birmingham, Birmingham, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Howard
authors.affiliation: Birmingham Clinical Trials Unit, University Hospitals Birmingham, Birmingham, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Magill
authors.affiliation: Department of Surgery, University Hospitals Leicester, Leicester, UK.
authors.forename: Baljit
authors.initials: B
authors.lastname: Singh
authors.affiliation: School of Immunity and Infection, University of Birmingham, Birmingham, UK.
authors.forename: Ye
authors.initials: Y
authors.lastname: Htun Oo
authors.affiliation: Department of Surgery, University Hospitals Birmingham, Birmingham, UK.
authors.forename: Dmitri
authors.initials: D
authors.lastname: Negpodiev
authors.affiliation: Clinical Research Unit, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Marcel Gw
authors.initials: MG
authors.lastname: Dijkgraaf
authors.affiliation: Department of Gastroenterology, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Geert
authors.initials: G
authors.lastname: Ram D'Haens
authors.affiliation: Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD, Amsterdam, The Netherlands. w.a.bemelman@amc.uva.nl.
authors.forename: Willem A
authors.initials: WA
authors.lastname: Bemelman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001062:Appendectomy / Q000379:methods; D002985:Clinical Protocols; D003093:Colitis, Ulcerative / Q000601:surgery*; D005260:Female; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D016896:Treatment Outcome