Email updates

Keep up to date with the latest news and content from BMC Surgery and BioMed Central.

Open Access Highly Accessed Study protocol

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

Emma J Eshuis12*, Willem A Bemelman2, Ad A van Bodegraven3, Mirjam AG Sprangers4, Patrick MM Bossuyt5, AW Marc van Milligen de Wit6, Rogier MPH Crolla7, Djuna L Cahen8, Liekele E Oostenbrug9, Meindert N Sosef10, Annet MCJ Voorburg11, Paul HP Davids12, C Janneke van der Woude13, Johan Lange14, Rosalie C Mallant15, Maarten J Boom16, Rob J Lieverse17, Edwin S van der Zaag18, Martin HMG Houben19, Juda Vecht20, Robert EGJM Pierik21, Theo JM van Ditzhuijsen22, Hubert A Prins23, Willem A Marsman24, Henricus B Stockmann25, Menno A Brink26, Esther CJ Consten27, Sjoerd DJ van der Werf28, Andreas WKS Marinelli29, Jeroen M Jansen30, Michael F Gerhards31, Clemens JM Bolwerk32, Laurents PS Stassen33, BW Marcel Spanier34, Ernst Jan Spillenaar Bilgen35, Anne-Marie van Berkel36, Huib A Cense37, Henk A van Heukelem38, Arnold van de Laar39, Warner Bruins Slot40, Quirijn A Eijsbouts41, Nancy AM van Ooteghem42, Bart van Wagensveld43, Jan MH van den Brande44, Anna AW van Geloven45, Karien F Bruin46, John K Maring47, Bas Oldenburg48, Richard van Hillegersberg49, Dirk J de Jong50, Robert Bleichrodt51, Donald L van der Peet52, Pascal EP Dekkers53, T Hauwy Goei54 and Pieter CF Stokkers1

Author Affiliations

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

For all author emails, please log on.

BMC Surgery 2008, 8:15  doi: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