TY - JOUR
T1 - Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)
AU - Eshuis, Emma J.
AU - Bemelman, Willem A.
AU - van Bodegraven, Ad A.
AU - Sprangers, Mirjam A. G.
AU - Bossuyt, Patrick M. M.
AU - van Milligen de Wit, A. W. Marc
AU - Crolla, Rogier M. P. H.
AU - Cahen, Djuna L.
AU - Oostenbrug, Liekele E.
AU - Sosef, Meindert N.
AU - Voorburg, Annet M. C. J.
AU - Davids, Paul H. P.
AU - van der Woude, C. Janneke
AU - Lange, Johan
AU - Mallant, Rosalie C.
AU - Boom, Maarten J.
AU - Lieverse, Rob J.
AU - van der Zaag, Edwin S.
AU - Houben, Martin H. M. G.
AU - Vecht, Juda
AU - Pierik, Robert E. G. J. M.
AU - van Ditzhuijsen, Theo J. M.
AU - Prins, Hubert A.
AU - Marsman, Willem A.
AU - Stockmann, Henricus B.
AU - Brink, Menno A.
AU - Consten, Esther C. J.
AU - van der Werf, Sjoerd D. J.
AU - Marinelli, Andreas W. K. S.
AU - Jansen, Jeroen M.
AU - Gerhards, Michael F.
AU - Bolwerk, Clemens J. M.
AU - Stassen, Laurents P. S.
AU - Spanier, B. W. Marcel
AU - Spillenaar Bilgen, Ernst Jan
AU - van Berkel, Anne-Marie
AU - Cense, Huib A.
AU - van Heukelem, Henk A.
AU - van de Laar, Arnold
AU - Slot, Warner Bruins
AU - Eijsbouts, Quirijn A.
AU - van Ooteghem, Nancy A. M.
AU - van Wagensveld, Bart
AU - van den Brande, Jan M. H.
AU - van Geloven, Anna A. W.
AU - Bruin, Karien F.
AU - Maring, John K.
AU - Oldenburg, Bas
AU - van Hillegersberg, Richard
AU - de Jong, Dirk J.
AU - Bleichrodt, Robert
AU - van der Peet, Donald L.
AU - Dekkers, Pascal E. P.
AU - Goei, T. Hauwy
AU - Stokkers, Pieter C. F.
AU - Eijsbouts, QA
PY - 2008
Y1 - 2008
N2 - 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
AB - 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
U2 - https://doi.org/10.1186/1471-2482-8-15
DO - https://doi.org/10.1186/1471-2482-8-15
M3 - Article
C2 - 18721465
SN - 1471-2482
VL - 8
SP - 15
JO - BMC Surgery
JF - BMC Surgery
IS - 1
ER -