It is beneficial to add intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation in Crohn's disease patients with symptomatic…
ID
Bron
Verkorte titel
Aandoening
Morbus Crohn
Status after ileocecal resection
Stenosis anastomosis
Ondersteuning
Department of Gastroenterology
Leiden Universitary Medical Center
Albinusdreef 2
Postbus 9600
2300 RC Leiden
The Netherlands
Tel.: ++31-71-5261838
Fax: ++31-71-5266979
E-mail: c.g.noomen@lumc.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate the benefit of the addition of intensive local anti-inflammatory therapy to routine enteric balloon dilatation in Crohn´s disease patients with symptomatic stenosis of the anastomosis.
Achtergrond van het onderzoek
The primary objective of this study is to evaluate the benefit of adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation in Crohn´s disease patients with symptomatic anastomosis
Doel van het onderzoek
It is beneficial to add intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation in Crohn's disease patients with symptomatic anastomosis.
Onderzoeksopzet
- Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks
- 1/10/2008 - 1/10/2010
Onderzoeksproduct en/of interventie
- Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks
- IBDQ, Harvey-Bradshaw score and VAS scores will be obtained at defined points.
- MR enterography will be performed.
- Colonoscopy with fluoroscopy under conscious sedation.
- Asessment of Rutgeerts score during colonoscopy.
- An EBD will be performed during the same colonoscopy session.
- At defined points blood samples will be taken
Publiek
Department of Gastroenterology
Postbus 9600
C.G. Noomen
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5261838
c.g.noomen@lumc.nl
Wetenschappelijk
Department of Gastroenterology
Postbus 9600
C.G. Noomen
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5261838
c.g.noomen@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Informed consent
2. Man or woman between 18 and 75 years of age
3. Established diagnosis of Crohn's disease
4. Negative stool culture (for exclusion of infectious ileocolitis and Clostridium Difficile infection)
5. History of ileocecal resection
6. Symptoms of intestinal obstruction;
- Intermittent abdominal pain
- Abdominal distension
- Nausea
- Vomiting
- Anorexia
- Significant stenotic segment (defined as a decrease in calibre of the intestinal lumen causing a pre-stenotic dilatation) located at the anastomosis as diagnosed with MR enterography.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. A stenotic segment of more than 6 cm
2. Rutgeerts score i4 inflammation at the site of stenosis
3. Fistulas at the site of stenosis or in the near proximity
4. A stenosis that cannot be properly endoscopically visualized
5. A significant stenosis proximal to the stenotic anastomosis
6. The concomitant use of other oral drugs containing budesonide within 4 weeks of screening
7. Oral antibiotics within 4 weeks of screening.
8. Pregnancy, lactation, or intended pregnancy or intended impregnation within 9 months
9. Serious secondary illnesses of an acute or chronic nature (e.g., acute cardiovascular disease, active infection)
10. Active infection
11. Known intolerance/hypersensitivity to the study drug
12. Well-founded doubt about the patient's cooperation and/or compliance
Opzet
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