NL-OMON38167已完成不适用
Endoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn*s disease with or without additive local steroid injection and oral Budenofalk* a double-blind, randomized, parallel group trial - ENDO ACE TRIA
niversitair Medisch Centrum Utrecht0 个研究点目标入组 42 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Informed consent
- •Man or woman 18 years or older
- •Established diagnosis of Crohn*s disease
- •Negative stool culture (at screening visit, for exclusion of infectious ileocolitis and Clostridium Difficile infection)
- •History of ileocecal resection
- •>= 2 Symptoms of intestinal obstruction
- •- Intermittent abdominal pain
- •- Abdominal distension
- •- Vomiting
- •- Anorexia
- •Significant stenotic segment (defined as a decrase in calibre of the intestinal lumen with or without a pre-stenotic dilatation) located at the anastomosis as diagnosed with MR enterography and transabdominal ultrasound
排除标准
- •A stenotic segment of more than 5 cm
- •Rutgeerts score i4 inflammation at the site of stenosis
- •Fistulas at the site of stenosis or in the near proximity
- •A stenosis that cannot be properly endoscopically visualized
- •A significant stenosis proximal to the stenosis at the site of the anastomosis`
- •The concomitant use of other oral drugs containing budesonide. A washout period of four weeks is applied.
- •Pregnancy, lactation, or intended pregnancy within 9 months
- •Serious secondary illnesses of an acute or chronic nature (e.g., acute cardiovascular disease, active infection)
- •Known intolerance/hypersensitivity to the study drug
- •Well-founded doubt about the patient*s cooperation
研究者
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ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIACrohn's disease.Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction.MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2007-005455-42-NLniversity Medical Center Utrecht42
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