Endoscopic Balloon Dilation as Compared to Surgical Management for the Treatment of Short Strictures in Fibrostenosing Crohns Disease: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Surgery-free period in patients with fibrostenotic Crohns disease
研究概览
简要总结
There is currently no standard management to guide the clinicians in treating patients with fibrostenotic disease. European Crohns and Colitis Organization [ECCO] recently developed a topical review on prediction, diagnosis and management of fibrostenosing Crohns disease. The review suggests endoscopic balloon dilation, strictureplasty, and intestinal resection as reasonable treatment options for short strictures based on the low grade of evidence.
详细描述
Study Population All patients with Crohns disease and a short stricture (<5 cm) within the reach of upper or lower GI endoscopy
Study Timeline
- Pre-recruitment phase including proposal, IRB approval, staff training, budget transfer - 9 months
- Recruitment of patients: 2 years
- Follow up: 2 years
- Analysis and preparing report: 6 months
Study Design Single blind randomized controlled trial The data will be blindly analyzed. Double blinding is not possible due to the nature of the study.
Study Methods Please see the study flow diagram below. Randomization will be done using computer software generating random numbers. Outcome Measures - A research associate will contact patients on weeks 1,2,4 and months 3,6,12,18 and 24 to record the items mentioned as secondary objectives of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 Patients with Crohns disease and a short stricture (<5 cm) within the reach of upper or lower GI endoscopy
排除标准
- •Abscess or phlegmon
- •High-grade dysplasia
- •Malignancy
- •Previous intervention
- •Pregnant women
研究组 & 干预措施
Surgery
Resection of the fibrostenotic area
干预措施: Surgery (Procedure)
Balloon dilation
TTS balloon dilation
干预措施: TTS balloon dilation (Procedure)
结局指标
主要结局
Surgery-free period in patients with fibrostenotic Crohns disease
时间窗: 2 years
The time to the need for first surgical treatment in following study intervention in each group
次要结局
未报告次要终点
研究者
Mohammad Yaghoobi
Assistant Professor of Medicine
McMaster University