Evidence map›Paper›PMID 18721465›Full record

Trial reportBMC surgery2008

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

Emma J Eshuis, Willem A Bemelman, Ad A van Bodegraven, Mirjam A G Sprangers, Patrick M M Bossuyt, A W Marc van Milligen de Wit, Rogier M P H Crolla, Djuna L Cahen, Liekele E Oostenbrug, Meindert N Sosef and 45 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC surgery, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02716454 (Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease - Prospective Randomized Study), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02716454 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease - Prospective Randomized Study

TypeinterventionalSponsorOndrej RyskaRan2016 to 2021Enrolled200ConditionsCrohn's DiseaseArmsIleocaecal resection
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Surgical Considerations in the Treatment of Small Bowel Crohn's Disease.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2017
    Review
  6. [Surgery in Crohn's disease].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2015
    Review
  7. Surgical management of IBD--from an open to a laparoscopic approach.Nature reviews. Gastroenterology & hepatology · 2013
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

55 authors at 20 institutions in 1 country.

Emma J EshuisDepartment of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands. e.j.eshuis@amc.uva.nl
Willem A Bemelman
Ad A van Bodegraven
Mirjam A G Sprangers
Patrick M M Bossuyt
A W Marc van Milligen de Wit
Rogier M P H Crolla
Djuna L Cahen
Liekele E Oostenbrug
Meindert N Sosef
Annet M C J Voorburg
Paul H P Davids
C Janneke van der Woude
Johan Lange
Rosalie C Mallant
Maarten J Boom
Rob J Lieverse
Edwin S van der Zaag
Martin H M G Houben
Juda Vecht
Robert E G J M Pierik
Theo J M van Ditzhuijsen
Hubert A Prins
Willem A Marsman
Henricus B Stockmann
Menno A Brink
Esther C J Consten
Sjoerd D J van der Werf
Andreas W K S Marinelli
Jeroen M Jansen
Michael F Gerhards
Clemens J M Bolwerk
Laurents P S Stassen
B W Marcel Spanier
Ernst Jan Spillenaar Bilgen
Anne-Marie van Berkel
Huib A Cense
Henk A van Heukelem
Arnold van de Laar
Warner Bruins Slot
Quirijn A Eijsbouts
Nancy A M van Ooteghem
Bart van Wagensveld
Jan M H van den Brande
Anna A W van Geloven
Karien F Bruin
John K Maring
Bas Oldenburg
Richard van Hillegersberg
Dirk J de Jong
Robert Bleichrodt
Donald L van der Peet
Pascal E P Dekkers
T Hauwy Goei
Pieter C F Stokkers
Academic Medical Center · NLAmphia Ziekenhuis · NLAmsterdam UMC Location VUmc · NLAtrium Medisch Centrum Parkstad · NLDiakonessenhuis hospital · NLElisabeth-TweeSteden Ziekenhuis · NLErasmus MC · NLGelre Hospitals · NLIsala · NLJeroen Bosch Ziekenhuis · NLMeander Medisch Centrum · NLMedisch Centrum Haaglanden · NLOLVG · NLReinier de Graaf Hospital · NLRijnstate Hospital · NLRode Kruis Ziekenhuis · NLSint Lucas Andreas Hospital · NLSlotervaartziekenhuis · NLSpaarne Gasthuis · NLSpaarne Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWith 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/

designThe 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 registrationNederlands Trial Register NTR1150.

Indexed as

Antibodies, MonoclonalAnti-Inflammatory AgentsColonCrohn DiseaseHumansIleumInfliximabLaparoscopyQuality of LifeRecurrenceAntibodies, MonoclonalAnti-Inflammatory AgentsInfliximab

Identifiers

PMID18721465
PMCPMC2533646
OpenAlexW1981704297

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.