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ClinicalTrials.gov ID

NCT02716454

Lead Sponsor

Ondrej RyskaOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

Apr 28, 2016Estimated

Start Date

May 2016

Primary Completion Date

May 2021Estimated

Completion Date

Dec 2021Estimated

Official Title

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

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.

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.

• Crohn's Disease

• Ileocaecal resection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Ondrej RyskaOTHER

shonova@nemcb.cz

sercl@seznam.cz

tomanovam@nemji.cz

lenka.nedbalova@nemlib.cz

kozeluhova@fnplzen.cz

lisy@fnkv.cz

karel.mares@homolka.cz

dana.duricova@seznam.cz