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Trial record 9 of 283 for:    Recruiting, Not yet recruiting, Available Studies | "Crohn's Disease"

Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease (ESPRIT)

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ClinicalTrials.gov Identifier: NCT02716454
Recruitment Status : Not yet recruiting
First Posted : March 23, 2016
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ondrej Ryska, Czech Surgical Society

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Procedure: Ileocaecal resection Not Applicable

Detailed Description:

Surgical therapy is currently indicated for Crohn's disease (CD) patients after conservative treatment becomes ineffective. The principles of so-called step-up therapy (STUP) where surgery represents the last therapeutical option are still followed.

Early surgical intervention (Early Surgery - ES) can be an alternative even in patients with uncomplicated type of CD before all medical therapy is used (Top-down approach). Limited resection under these conditions will lead to immediate remission. Moreover, laparoscopic ileocaecal resection is safe with low morbidity and regarding potential complications of step-up treatment might be beneficial for the patient.

Before wide introduction of ES approach into clinical practice, it is necessary to perform a randomized trial comparing early resection with the standard step-up medical therapy.

The potential effect of early, intensive therapy (ileocaecal resection) on biological behavior of the disease has not been studied that is why patients with uncomplicated ileocaecal form are the most suitable for such a trial. Significant number of these patients will indeed progress into more unfavorable course of the disease (relapse, complicated form, early recurrence).

Other potential benefit of early resection is the extended period without necessary medication. Even pharmacological recurrence prevention is not needed after surgery in uncomplicated CD patient if other risk factors are excluded. Rapid remission induced by surgery can lead to faster improvement of quality of life than long-term medication.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease - Prospective Randomized Study
Study Start Date : May 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Early Surgery - ES
Early laparoscopic ileocaecal resection
Procedure: Ileocaecal resection
laparoscopic ileocaecal resection with primary anastomosis

No Intervention: Step-up therapy - STUP
Treatment with step-up conservative approach according to good clinical practice.



Primary Outcome Measures :
  1. Endoscopic remission [ Time Frame: 24 months ]
    The rate of endoscopic remission defined as Rutgeerts score ≤ 1 and SES-CD = 0 in early surgery and standard step-up therapy group respectively


Secondary Outcome Measures :
  1. QoL [ Time Frame: 24 months ]
    Quality of life measured by IBDQ, IBD Disability index

  2. Clinical remission [ Time Frame: 24 months ]
    Clinical remission defined by Crohn's disease activity index < 150

  3. Drug consumption [ Time Frame: 24 months ]
    Overall drug consumption (corticosteroids, antibiotics, immunomodulators, biologic therapy)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • 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

Exclusion Criteria:

  • 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

Other exclusion criteria:

  • Different intraoperative finding
  • Protocol violation
  • Subject refuses further participation in the study
  • Termination of the trial by responsible authority

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716454


Contacts
Contact: Ondrej Ryska, Dr, PhD 606254686 ext 00420 ondrejryska@centrum.cz

Locations
Czech Republic
The University Hospital Brno Not yet recruiting
Brno, Czech Republic, 625 00
Contact: Lenka Prokopova, Dr.       lprokopova@fnbrno.cz   
Contact: Filip Marek, Dr.       fmarek@fnbrno.cz   
Hospital Ceske Budejovice Not yet recruiting
Ceske Budejovice, Czech Republic, 370 01
Contact: Olga Shonova, Dr.       shonova@nemcb.cz   
Contact: M Kobza, Dr.       mkobza@seznam.cz   
Horovice Hospital Not yet recruiting
Horovice, Czech Republic, 26831
Contact: Zuzana Serclova, Dr       sercl@seznam.cz   
Universitiy Hospital Hradec Kralove Not yet recruiting
Hradec Kralove, Czech Republic, 50005
Contact: Julius Orhalmi, Dr.       orhalmi@volny.cz   
Hospital Jihlava Not yet recruiting
Jihlava, Czech Republic, 586 33
Contact: Marie Tomanova, Dr.       tomanovam@nemji.cz   
Hospital Liberec Not yet recruiting
Liberec, Czech Republic, 460 63
Contact: Lenka Nedbalova, Dr.       lenka.nedbalova@nemlib.cz   
Vitkovice Hospital
Ostrava - Vitkovice, Czech Republic, 703 84
University Hospital in Pilsen Not yet recruiting
Pilsen, Czech Republic, 323 18
Contact: Jana Kozeluhova, Dr.       kozeluhova@fnplzen.cz   
Royal Vinohrady University Hospital Not yet recruiting
Prague, Czech Republic, 100 34
Contact: Pavel Lisý, Dr.       lisy@fnkv.cz   
Institute for Clinical and Experimental Medicine Not yet recruiting
Prague, Czech Republic, 140 21
Contact: Pavel Drastich, Dr.       drastich@hotmail.com   
Na Homolce Hospital Not yet recruiting
Prague, Czech Republic, 150 00
Contact: Karel Mareš, Dr       karel.mares@homolka.cz   
ISCARE Not yet recruiting
Prague, Czech Republic, 170 00
Contact: Dana Duricova, Dr       dana.duricova@seznam.cz   
Sponsors and Collaborators
Ondrej Ryska
Investigators
Principal Investigator: Ondrej Ryska, Dr, PhD Section of IBD surgery - Czech Surgical Society

Publications of Results:
Other Publications:
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.

Responsible Party: Ondrej Ryska, investigator secretary in section of IBD surgery Czech Surgical Society, Czech Surgical Society
ClinicalTrials.gov Identifier: NCT02716454     History of Changes
Other Study ID Numbers: IBDchirCZ-01
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ondrej Ryska, Czech Surgical Society:
Early surgery
Crohn's disease
Step-up therapy

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases