Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Procedure: Ileocaecal resection
- Registration Number
- NCT02716454
- Lead Sponsor
- Ondrej Ryska
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Surgery - ES Ileocaecal resection Early laparoscopic ileocaecal resection
- Primary Outcome Measures
Name Time Method Endoscopic remission 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
Name Time Method QoL 24 months Quality of life measured by IBDQ, IBD Disability index
Clinical remission 24 months Clinical remission defined by Crohn's disease activity index \< 150
Drug consumption 24 months Overall drug consumption (corticosteroids, antibiotics, immunomodulators, biologic therapy)
Trial Locations
- Locations (12)
University Hospital in Pilsen
🇨🇿Pilsen, Czech Republic
Institute for Clinical and Experimental Medicine
🇨🇿Prague, Czech Republic
Na Homolce Hospital
🇨🇿Prague, Czech Republic
The University Hospital Brno
🇨🇿Brno, Czech Republic
Horovice Hospital
🇨🇿Horovice, Czech Republic
Hospital Ceske Budejovice
🇨🇿Ceske Budejovice, Czech Republic
Hospital Jihlava
🇨🇿Jihlava, Czech Republic
Royal Vinohrady University Hospital
🇨🇿Prague, Czech Republic
ISCARE
🇨🇿Prague, Czech Republic
Universitiy Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Hospital Liberec
🇨🇿Liberec, Czech Republic
Vitkovice Hospital
🇨🇿Ostrava - Vitkovice, Czech Republic