NCT02716454

Brief Summary

This study compares the efficacy of early surgical with medical treatment in patients with ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up pharmacological therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

5 years

First QC Date

March 17, 2016

Last Update Submit

April 26, 2016

Conditions

Crohn's Disease

Keywords

Early surgeryCrohn's diseaseStep-up therapy

Outcome Measures

Primary Outcomes (1)

  • Endoscopic remission

    The rate of endoscopic remission defined as Rutgeerts score ≤ 1 and SES-CD = 0 in early surgery and standard step-up therapy group respectively

    24 months

Secondary Outcomes (3)

  • QoL

    24 months

  • Clinical remission

    24 months

  • Drug consumption

    24 months

Study Arms (2)

Early Surgery - ES

EXPERIMENTAL

Early laparoscopic ileocaecal resection

Procedure: Ileocaecal resection

Step-up therapy - STUP

NO INTERVENTION

Treatment with step-up conservative approach according to good clinical practice.

Interventions

Ileocaecal resectionPROCEDURE

laparoscopic ileocaecal resection with primary anastomosis

Early Surgery - ES

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients aged 18-65 years with a uncomplicated ileocaecal form of Crohn's disease (affected \< 20 cm of terminal ileum) (type: L1B1) diagnosed within last 12 months
  • Diagnose confirmed by endoscopy including appropriate extent of disease and presence of ulcers in terminal ileum
  • Patient is able to understand the study and sign an informed consent

You may not qualify if:

  • Pregnant or breastfeeding women
  • Previous bowel resection or other extensive abdominal surgery, which primarily excludes laparoscopic approach
  • Affected other parts of the digestive tract or symptomatic stenosis or stenosis impassable for the endoscope or presence of prestenotic dilatation in terminal ileum confirmed by enterography
  • Any extraluminal complications of Crohn's disease (fistula, abscess)
  • Affected part of terminal ileum longer than 20 cm
  • Severe comorbidities (heart failure, renal failure, liver failure, severe disorders of the central and peripheral nervous system, serious infectious disease) or patient with ASA (American Society of Anesthesiologists) III and more
  • Malnutrition or presence of another serious risk factor, which contradicts construction of primary anastomosis
  • Current use of immunosuppressive or biologic therapy
  • Different intraoperative finding
  • Protocol violation
  • Subject refuses further participation in the study
  • Termination of the trial by responsible authority

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

The University Hospital Brno

Brno, 625 00, Czechia

Location

Hospital Ceske Budejovice

České Budějovice, 370 01, Czechia

Location

Horovice Hospital

Hořovice, 26831, Czechia

Location

Universitiy Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Hospital Jihlava

Jihlava, 586 33, Czechia

Location

Hospital Liberec

Liberec, 460 63, Czechia

Location

Vitkovice Hospital

Ostrava - Vitkovice, 703 84, Czechia

Location

University Hospital in Pilsen

Pilsen, 323 18, Czechia

Location

Royal Vinohrady University Hospital

Prague, 100 34, Czechia

Location

Institute for Clinical and Experimental Medicine

Prague, 140 21, Czechia

Location

Na Homolce Hospital

Prague, 150 00, Czechia

Location

ISCARE

Prague, 170 00, Czechia

Location

Related Publications (10)

  • Jess T, Riis L, Vind I, Winther KV, Borg S, Binder V, Langholz E, Thomsen OO, Munkholm P. Changes in clinical characteristics, course, and prognosis of inflammatory bowel disease during the last 5 decades: a population-based study from Copenhagen, Denmark. Inflamm Bowel Dis. 2007 Apr;13(4):481-9. doi: 10.1002/ibd.20036.

    PMID: 17206705BACKGROUND

  • Domenech E, Zabana Y, Garcia-Planella E, Lopez San Roman A, Nos P, Ginard D, Gordillo J, Martinez-Silva F, Beltran B, Manosa M, Cabre E, Gassull MA. Clinical outcome of newly diagnosed Crohn's disease: a comparative, retrospective study before and after infliximab availability. Aliment Pharmacol Ther. 2010 Jan 15;31(2):233-9. doi: 10.1111/j.1365-2036.2009.04170.x. Epub 2009 Oct 13.

    PMID: 19832727BACKGROUND

  • Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. doi: 10.1136/gut.2004.045294.

    PMID: 15647188BACKGROUND

  • Golovics PA, Lakatos L, Nagy A, Pandur T, Szita I, Balogh M, Molnar C, Komaromi E, Lovasz BD, Mandel M, Veres G, Kiss LS, Vegh Z, Lakatos PL. Is early limited surgery associated with a more benign disease course in Crohn's disease? World J Gastroenterol. 2013 Nov 21;19(43):7701-10. doi: 10.3748/wjg.v19.i43.7701.

    PMID: 24282358BACKGROUND

  • Eshuis EJ, Bemelman WA, van Bodegraven AA, Sprangers MA, Bossuyt PM, van Milligen de Wit AW, Crolla RM, Cahen DL, Oostenbrug LE, Sosef MN, Voorburg AM, Davids PH, van der Woude CJ, Lange J, Mallant RC, Boom MJ, Lieverse RJ, van der Zaag ES, Houben MH, Vecht J, Pierik RE, van Ditzhuijsen TJ, Prins HA, Marsman WA, Stockmann HB, Brink MA, Consten EC, van der Werf SD, Marinelli AW, Jansen JM, Gerhards MF, Bolwerk CJ, Stassen LP, Spanier BW, Bilgen EJ, van Berkel AM, Cense HA, van Heukelem HA, van de Laar A, Slot WB, Eijsbouts QA, van Ooteghem NA, van Wagensveld B, van den Brande JM, van Geloven AA, Bruin KF, Maring JK, Oldenburg B, van Hillegersberg R, de Jong DJ, Bleichrodt R, van der Peet DL, Dekkers PE, Goei TH, Stokkers PC. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial). BMC Surg. 2008 Aug 22;8:15. doi: 10.1186/1471-2482-8-15.

    PMID: 18721465BACKGROUND

  • Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn's disease. Gastroenterology. 1990 Oct;99(4):956-63. doi: 10.1016/0016-5085(90)90613-6.

    PMID: 2394349BACKGROUND

  • Peyrin-Biroulet L, Cieza A, Sandborn WJ, Coenen M, Chowers Y, Hibi T, Kostanjsek N, Stucki G, Colombel JF; International Programme to Develop New Indexes for Crohn's Disease (IPNIC) group. Development of the first disability index for inflammatory bowel disease based on the international classification of functioning, disability and health. Gut. 2012 Feb;61(2):241-7. doi: 10.1136/gutjnl-2011-300049. Epub 2011 Jun 5.

    PMID: 21646246BACKGROUND

  • Dignass A, Van Assche G, Lindsay JO, Lemann M, Soderholm J, Colombel JF, Danese S, D'Hoore A, Gassull M, Gomollon F, Hommes DW, Michetti P, O'Morain C, Oresland T, Windsor A, Stange EF, Travis SP; European Crohn's and Colitis Organisation (ECCO). The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Current management. J Crohns Colitis. 2010 Feb;4(1):28-62. doi: 10.1016/j.crohns.2009.12.002. Epub 2010 Jan 15. No abstract available.

    PMID: 21122489BACKGROUND

  • Maartense S, Dunker MS, Slors JF, Cuesta MA, Pierik EG, Gouma DJ, Hommes DW, Sprangers MA, Bemelman WA. Laparoscopic-assisted versus open ileocolic resection for Crohn's disease: a randomized trial. Ann Surg. 2006 Feb;243(2):143-9; discussion 150-3. doi: 10.1097/01.sla.0000197318.37459.ec.

    PMID: 16432345BACKGROUND

  • Aratari A, Papi C, Leandro G, Viscido A, Capurso L, Caprilli R. Early versus late surgery for ileo-caecal Crohn's disease. Aliment Pharmacol Ther. 2007 Nov 15;26(10):1303-12. doi: 10.1111/j.1365-2036.2007.03515.x. Epub 2007 Sep 10.

    PMID: 17848181RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Ondrej Ryska, Dr, PhD

    Section of IBD surgery - Czech Surgical Society

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ondrej Ryska, Dr, PhD

CONTACT

606254686ondrejryska@centrum.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
investigator secretary in section of IBD surgery Czech Surgical Society

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 23, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2021

Study Completion

December 1, 2021

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

CZ(12)