No registrations found.
ID
Source
Brief title
Health condition
Morbus Crohn
Status after ileocecal resection
Stenosis anastomosis
Sponsors and support
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
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
- To assess the feasibility of radiologic imaging of the anastomosis in the endoscopy suite, and validating Radiological Crohn´s Disease Anastomotic Index (RCDAI).
- To assess the safety of EBD procedure in combination with local intensive therapy
Background summary
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
Study objective
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.
Study design
- Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks
- 1/10/2008 - 1/10/2010
Intervention
- 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
Department of Gastroenterology
Postbus 9600
C.G. Noomen
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5261838
c.g.noomen@lumc.nl
Department of Gastroenterology
Postbus 9600
C.G. Noomen
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5261838
c.g.noomen@lumc.nl
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1321 |
| NTR-old | NTR1378 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |