1. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)
- Author
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van Heukelem Henk A, Cense Huib A, van Berkel Anne-Marie, Bilgen Ernst, Spanier BW Marcel, Stassen Laurents PS, Bolwerk Clemens JM, Gerhards Michael F, Jansen Jeroen M, Marinelli Andreas WKS, van der Werf Sjoerd DJ, Consten Esther CJ, Brink Menno A, Stockmann Henricus B, Marsman Willem A, Prins Hubert A, van Ditzhuijsen Theo JM, Pierik Robert EGJM, Vecht Juda, Houben Martin HMG, van der Zaag Edwin S, Lieverse Rob J, Boom Maarten J, Mallant Rosalie C, Lange Johan, van der Woude C Janneke, Davids Paul HP, Voorburg Annet MCJ, Sosef Meindert N, Oostenbrug Liekele E, Cahen Djuna L, Crolla Rogier MPH, de Wit AW, Bossuyt Patrick MM, Sprangers Mirjam AG, van Bodegraven Ad A, Bemelman Willem A, Eshuis Emma J, van de Laar Arnold, Slot Warner, Eijsbouts Quirijn A, van Ooteghem Nancy AM, van Wagensveld Bart, van den Brande Jan MH, van Geloven Anna AW, Bruin Karien F, Maring John K, Oldenburg Bas, van Hillegersberg Richard, de Jong Dirk J, Bleichrodt Robert, van der Peet Donald L, Dekkers Pascal EP, Goei T Hauwy, and Stokkers Pieter CF
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Surgery ,RD1-811 - Abstract
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
- Published
- 2008
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