Endoscopic Balloon Dilatation of narrowed intestinal connection in Crohn's disease with or without extra local medicatio
- Conditions
- Morbus CrohnStatus after ileocecal resectionStenosis anastomosis
- Registration Number
- NL-OMON24606
- Lead Sponsor
- Drs. C.G. NoomenDepartment of GastroenterologyLeiden Universitary Medical CenterAlbinusdreef 2Postbus 96002300 RC LeidenThe NetherlandsTel.: ++31-71-5261838Fax: ++31-71-5266979E-mail: c.g.noomen@lumc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
1. Informed consent
2. Man or woman between 18 and 75 years of age
Exclusion Criteria
1. A stenotic segment of more than 6 cm
2. Rutgeerts score i4 inflammation at the site of stenosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method - To assess the feasibility of radiologic imaging of the anastomosis in the endoscopy suite, and validating Radiological Crohn´s Disease Anastomotic Index (RCDAI). <br /><br>- To assess the safety of EBD procedure in combination with local intensive therapy<br>