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Open AccessStudy protocol

Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)

Emma J Eshuis1,2 email, Willem A Bemelman2 email, Ad A van Bodegraven3 email, Mirjam AG Sprangers4 email, Patrick MM Bossuyt5 email, AW Marc van Milligen de Wit6 email, Rogier MPH Crolla7 email, Djuna L Cahen8 email, Liekele E Oostenbrug9 email, Meindert N Sosef10 email, Annet MCJ Voorburg11 email, Paul HP Davids12 email, C Janneke van der Woude13 email, Johan Lange14 email, Rosalie C Mallant15 email, Maarten J Boom16 email, Rob J Lieverse17 email, Edwin S van der Zaag18 email, Martin HMG Houben19 email, Juda Vecht20 email, Robert EGJM Pierik21 email, Theo JM van Ditzhuijsen22 email, Hubert A Prins23 email, Willem A Marsman24 email, Henricus B Stockmann25 email, Menno A Brink26 email, Esther CJ Consten27 email, Sjoerd DJ van der Werf28 email, Andreas WKS Marinelli29 email, Jeroen M Jansen30 email, Michael F Gerhards31 email, Clemens JM Bolwerk32 email, Laurents PS Stassen33 email, BW Marcel Spanier34 email, Ernst Jan Spillenaar Bilgen35 email, Anne-Marie van Berkel36 email, Huib A Cense37 email, Henk A van Heukelem38 email, Arnold van de Laar39 email, Warner Bruins Slot40 email, Quirijn A Eijsbouts41 email, Nancy AM van Ooteghem42 email, Bart van Wagensveld43 email, Jan MH van den Brande44 email, Anna AW van Geloven45 email, Karien F Bruin46 email, John K Maring47 email, Bas Oldenburg48 email, Richard van Hillegersberg49 email, Dirk J de Jong50 email, Robert Bleichrodt51 email, Donald L van der Peet52 email, Pascal EP Dekkers53 email, T Hauwy Goei54 email and Pieter CF Stokkers1 email

1  Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands

2  Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands

3  Department of Gastroenterology and Hepatology, VU Medical Center, Amsterdam, The Netherlands

4  Department of Medical Psychology, Academic Medical Center, Amsterdam, The Netherlands

5  Department of Clinical Epidemiology and Bio-statistics, Academic Medical Center, Amsterdam, The Netherlands

6  Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, The Netherlands

7  Department of Surgery, Amphia Hospital, Breda, The Netherlands

8  Department of Gastroenterology and Hepatology, Amstelland hospital, Amstelveen, The Netherlands

9  Department of Gastroenterology and Hepatology, Atrium Medical Center, Heerlen, The Netherlands

10  Department of Surgery, Atrium Medical Center, Heerlen, The Netherlands

11  Department of Gastroenterology and Hepatology, Diakonessen Hospital, Utrecht, The Netherlands

12  Department of Surgery, Diakonessen Hospital, Utrecht, The Netherlands

13  Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands

14  Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands

15  Department of Gastroenterology and Hepatology, Flevo Hospital, Almere, The Netherlands

16  Department of Surgery, Flevo Hospital, Almere, The Netherlands

17  Department of Gastroenterology and Hepatology, Gelre Hospital, Apeldoorn, The Netherlands

18  Department of Surgery, Gelre Hospital, Apeldoorn, The Netherlands

19  Department of Gastroenterology and Hepatology, Haga Teaching Hospital, Den Haag, The Netherlands

20  Department of Gastroenterology and Hepatology, Isala Hospital, Zwolle, The Netherlands

21  Department of Surgery, Isala Hospital, Zwolle, The Netherlands

22  Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands

23  Department of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands

24  Department of Gastroenterology and Hepatology, Kennemer Gasthuis, Haarlem, The Netherlands

25  Department of Surgery, Kennemer Gasthuis, Haarlem, The Netherlands

26  Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, The Netherlands

27  Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands

28  Department of Gastroenterology and Hepatology, Medical Center Haaglanden, Den Haag, The Netherlands

29  Department of surgery, Medical Center Haaglanden, Den Haag, The Netherlands

30  Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

31  Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

32  Department of Gastroenterology and Hepatology, Reinier de Graaf Gasthuis, Delft, The Netherlands

33  Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands

34  Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The Netherlands

35  Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands

36  Department of Gastroenterology and Hepatology, Rode Kruis Hospital, Beverwijk, The Netherlands

37  Department of Surgery, Rode Kruis Hospital, Beverwijk, The Netherlands

38  Department of Gastroenterology and Hepatology, Slotervaart Hospital, Amsterdam, The Netherlands

39  Department of Surgery, Slotervaart Hospital, Amsterdam, The Netherlands

40  Department of Gastroenterology and Hepatology, Spaarne Hospital, Hoofddorp, The Netherlands

41  Department of Surgery, Spaarne Hospital, Hoofddorp, The Netherlands

42  Department of Gastroenterology and Hepatology, St Lucas Andreas Hospital, Amsterdam, The Netherlands

43  Department of Surgery, St Lucas Andreas Hospital, Amsterdam, The Netherlands

44  Department of Gastroenterology and Hepatology, Tergooi Hospitals, Hilversum, The Netherlands

45  Department of Surgery, Tergooi Hospitals, Hilversum, The Netherlands

46  Department of Gastroenterology and Hepatology, Twee Steden Hospital, Tilburg, The Netherlands

47  Department of Surgery, Twee Steden Hospital, Tilburg, The Netherlands

48  Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands

49  Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands

50  Department of Gastroenterology and Hepatology, St Radboud University Medical Center, Nijmegen, The Netherlands

51  Department of Surgery, St Radboud University Medical Center, Nijmegen, The Netherlands

52  Department of Surgery, VU Medical Center, Amsterdam, The Netherlands

53  Department of Gastroenterology and Hepatology, Zaans Medical Center, Zaandam, The Netherlands

54  Department of Surgery, Zaans Medical Center, Zaandam, The Netherlands

author email corresponding author email

BMC Surgery 2008, 8:15doi:10.1186/1471-2482-8-15

Published: 22 August 2008

Abstract

Background

With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.

The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs.

Methods/design

The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007.

Discussion

The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease.

Trial registration

Nederlands Trial Register NTR1150

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