Crohn's Disease Clinical Trial
Official title:
Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease - Prospective Randomized Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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