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

Willem A Bemelman^2,21  Geert RAM D’Haens⁶  Marcel GW Dijkgraaf¹  Dmitri Negpodiev^1,19  Ye Htun Oo^1,17  Baljit Singh²  Laura Magill^2,20  Rebecca Howard^2,20  Shrikanth Pathmakanthan^2,24  Tariq Iqbal^2,24  Rachel West^1,13  Guido HH Mannaerts^1,18  Annekatrien CTM Depla⁴  Yair Acherman⁸  Jeroen M Jansen^2,22  Michael F Gerhards^1,11  Pieter CF Stokkers⁹  Bart A van Wagensveld³  Annick B van Nunen^2,25  Meindert N Sosef^1,15  Juda Vecht⁵  Robert EGJM Pierik^2,23  Rosalie C Mallant-Hent⁷  Maarten J Boom^1,16  Tom Seerden^1,10  Paul HJM Pullens^1,12  Ivo AMJ Broeders^1,14  Gijs R van den Brink⁶  Mark Löwenberg⁶  Pieter J Tanis^2,21  Cyriel Y Ponsioen⁶  Christianne J Buskens^2,21  Dion G Morton^1,19  Saloomeh Sahami^2,21  Thomas D Pinkney^1,19  Tjibbe J Gardenbroek^2,21 

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

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

Others  :  1161335
DOI  :  10.1186/s12893-015-0017-1

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

【 摘 要 】

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/Design

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.

Discussion

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.

Trial registration

NTR2883 webcite; ISRCTN56523019 webcite

【 授权许可】

   
2015 Gardenbroek et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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