Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).
研究概览
简要总结
Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.
详细描述
Prospective randomised controlled study. Patients with Crohn's Disease and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.
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
- None
盲法说明
Open label study
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
- •Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.
排除标准
- •Acute bowel obstruction requiring urgent surgical intervention
- •Deemed by treating physician to have high risk of acute bowel obstruction
- •Concurrent active perianal sepsis
- •Internal fistulising disease in association with strictures (entero-enteric stulas)
- •Low rectal or anal strictures
- •Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
- •Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
- •Inability to give informed consent
- •Suspected perforation of the gastrointestinal tract
- •Pregnancy
- •Inability to undergo MRI small bowel due to a contraindication.
结局指标
主要结局
Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).
时间窗: 6 months
The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (no pain, mild, moderate, severe, unbearable)
次要结局
- Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS).(3, 6 and 12 months)
- Improvement in imaging parameters(6 months)
- Improvement in endoscopic features(6 months)
- Avoidance of surgery(6 months)
- Technical success of procedure(At time of procedure)
- Improvement in patient reported outcomes (PROs)(6 months)
研究者
Michael Kamm
Professor of Gastroenterology
St Vincent's Hospital Melbourne