K50.9
Conditions
Interventions
Group 1: Endoscopic balloon dilatation of crohn stenoses < 5 cm without ulcer or fistula with through-the-scope (TTS) balloons.
The theurapeutic intervnetion is not part of the study, the clinical an
Sponsors
Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie, RheumatologieZentrale Endoskopioe
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria were: 1. patients with crohn’s disease between 18-80 years 2. symptomatic crohn stenosis (we expect 80-90% stenosis of anastomosis and 10-20 % stenosis in patients without previous surgical therapy) 3. signed consent to participate into the study
Exclusion criteria
Exclusion criteria: Exclusion criteria were: 1. Patients with previous endoscopic dilatation therapy 2. length of stenosis > 5 cm 3. fistula and/or ulcer in the area of stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is the evaluation of treatment success of the endoscopic balloon dilation which is defined as surgical-free and re-dilation-free time after first dilation. The follow-up will be 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points are the influence of the inflammatory activity, smoking habits, effect of anti-inflammatory treatment on the success or side effect rate and the effect of the stenosis length. It should be evaluated how often patients need surgery or continued endoscopic therapy after the first dilation. Further end points were clinical symptoms and the complication rate of the initial intervention. SAEs and clinical data will be documented intially and 1 and 2 years after inclusion. In case of further interventions within the study period more CRFs will be documented. | — |
Countries
Germany
Contacts
Public ContactChristian Bojarski
Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie, RheumatologieZentrale Endoskopioe
Outcome results
None listed