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


CONCLUSIONS
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.


BACKGROUND
Nederlands Trial Register NTR1150.
Eshuis
Emma J
EJ
Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands. e.j.eshuis@amc.uva.nl
Bemelman
Willem A
WA
van Bodegraven
Ad A
AA
Sprangers
Mirjam A G
MA
Bossuyt
Patrick M M
PM
van Milligen de Wit
A W Marc
AW
Crolla
Rogier M P H
RM
Cahen
Djuna L
DL
Oostenbrug
Liekele E
LE
Sosef
Meindert N
MN
Voorburg
Annet M C J
AM
Davids
Paul H P
PH
van der Woude
C Janneke
CJ
Lange
Johan
J
Mallant
Rosalie C
RC
Boom
Maarten J
MJ
Lieverse
Rob J
RJ
van der Zaag
Edwin S
ES
Houben
Martin H M G
MH
Vecht
Juda
J
Pierik
Robert E G J M
RE
van Ditzhuijsen
Theo J M
TJ
Prins
Hubert A
HA
Marsman
Willem A
WA
Stockmann
Henricus B
HB
Brink
Menno A
MA
Consten
Esther C J
EC
van der Werf
Sjoerd D J
SD
Marinelli
Andreas W K S
AW
Jansen
Jeroen M
JM
Gerhards
Michael F
MF
Bolwerk
Clemens J M
CJ
Stassen
Laurents P S
LP
Spanier
B W Marcel
BW
Bilgen
Ernst Jan Spillenaar
EJ
van Berkel
Anne-Marie
AM
Cense
Huib A
HA
van Heukelem
Henk A
HA
van de Laar
Arnold
A
Slot
Warner Bruins
WB
Eijsbouts
Quirijn A
QA
van Ooteghem
Nancy A M
NA
van Wagensveld
Bart
B
van den Brande
Jan M H
JM
van Geloven
Anna A W
AA
Bruin
Karien F
KF
Maring
John K
JK
Oldenburg
Bas
B
van Hillegersberg
Richard
R
de Jong
Dirk J
DJ
Bleichrodt
Robert
R
van der Peet
Donald L
DL
Dekkers
Pascal E P
PE
Goei
T Hauwy
TH
Stokkers
Pieter C F
PC
D000893:Anti-Inflammatory Agents / Q000191:economics / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use*; D003106:Colon / Q000601:surgery*; D003424:Crohn Disease / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007082:Ileum / Q000601:surgery*; D000069285:Infliximab; D010535:Laparoscopy / Q000191:economics*; D011788:Quality of Life; D012008:Recurrence
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab