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)

BMC Surgery

Study Protocol

Rebecca Howard¹  Laura Magill¹  Marcel GW Dijkgraaf²  Geert RAM D’Haens³  Cyriel Y Ponsioen³  Mark Löwenberg³  Gijs R van den Brink³  Tom Seerden⁴  Annick B van Nunen⁵  Rosalie C Mallant-Hent⁶  Juda Vecht⁷  Pieter CF Stokkers⁸  Paul HJM Pullens⁹  Jeroen M Jansen^1,10  Annekatrien CTM Depla^1,11  Rachel West^1,12  Shrikanth Pathmakanthan^1,13  Tariq Iqbal^1,13  Christianne J Buskens^1,14  Pieter J Tanis^1,14  Tjibbe J Gardenbroek^1,14  Willem A Bemelman^1,14  Saloomeh Sahami^1,14  Meindert N Sosef^1,15  Maarten J Boom^1,16  Robert EGJM Pierik^1,17  Bart A van Wagensveld^1,18  Ivo AMJ Broeders^1,19  Michael F Gerhards^2,20  Yair Acherman^2,21  Guido HH Mannaerts^2,22  Dion G Morton^2,23  Thomas D Pinkney^2,23  Dmitri Negpodiev^2,23  Baljit Singh^2,24  Ye Htun Oo^2,25 

[1] Birmingham Clinical Trials Unit, University Hospitals Birmingham, Birmingham, UK;Clinical Research Unit, Academic Medical Centre, Amsterdam, The Netherlands;Department of Gastroenterology, Academic Medical Centre, Amsterdam, The Netherlands;Department of Gastroenterology, Amphia Hospital, Breda, The Netherlands;Department of Gastroenterology, Atrium Medical Center, Heerlen, The Netherlands;Department of Gastroenterology, Flevo Hospital, Almere, The Netherlands;Department of Gastroenterology, Isala Hospital, Zwolle, The Netherlands;Department of Gastroenterology, Lucas Andreas Hospital, Amsterdam, The Netherlands;Department of Gastroenterology, Meander Medical Center, Amersfoort, The Netherlands;Department of Gastroenterology, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands;Department of Gastroenterology, Slotervaart Hospital, Amsterdam, The Netherlands;Department of Gastroenterology, St. Franciscus Hospital, Rotterdam, The Netherlands;Department of Gastroenterology, University Hospitals Birmingham, Birmingham, UK;Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD, Amsterdam, The Netherlands;Department of Surgery, Atrium Medical Center, Heerlen, The Netherlands;Department of Surgery, Flevo Hospital, Almere, The Netherlands;Department of Surgery, Isala Hospital, Zwolle, The Netherlands;Department of Surgery, Lucas Andreas Hospital, Amsterdam, The Netherlands;Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands;Department of Surgery, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands;Department of Surgery, Slotervaart Hospital, Amsterdam, The Netherlands;Department of Surgery, St. Franciscus Hospital, Rotterdam, The Netherlands;Department of Surgery, University Hospitals Birmingham, Birmingham, UK;Department of Surgery, University Hospitals Leicester, Leicester, UK;School of Immunity and Infection, University of Birmingham, Birmingham, UK;

关键词: Inflammatory bowel disease;    Ulcerative colitis;    Appendectomy;    Surgery;    Disease course;   

DOI  :  10.1186/s12893-015-0017-1

 received in 2014-11-30, accepted in 2015-02-26,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundOver 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/DesignThese 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.DiscussionThe 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.Trial registrationNTR2883; ISRCTN56523019

【 授权许可】

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© Gardenbroek et al.; licensee BioMed Central. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.