NCT07264413尚未招募不适用
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Cardiovascular and Interventional Radiological Society of Europe0 个研究点目标入组 250 人开始时间: 2026年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- Haemorrhoidal bleeding
研究概览
简要总结
BRIGHT is a Europe-wide study that will follow up to 250 adults with bleeding symptoms from haemmorhoids (Grade II-III categories). It aims to understand how well a minimally invasive procedure called haemorrhoid artery embolization (HAE) works in everyday clinical practice, which is a technique that blocks the blood vessels feeding the haemorrhoids. As this technique does not require major surgery, HAE offers several benefits such as less trauma, quicker recovery, and the use of only local anaesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients presenting bleeding Grade II-III haemorrhoids with French bleeding score ≥3 planned to be treated with HAE using embolization coils;
- •Patients competent and willing to give written informed consent.
排除标准
- •Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);
- •Patients receiving HAE using a combination of coils and particles, particles only, or any other embolic agents;
- •Patients who have had previous surgical haemorrhoidectomy at any time or other treatments for haemorrhoids within 1 year before the planned HAE;
- •Patients with known perianal sepsis, inflammatory bowel disease, peri-anal fistula, colorectal malignancy or pre-existing sphincter injury resulting in incontinence;
- •Patients with an immunodeficiency;
- •Known severe atheromatous disease with occlusion of target vessels preventing embolization;
- •Absolute contraindication to contrast media;
- •ECOG performance status > 2;
- •Life expectancy < 12 months;
- •Patients with unstable angina;
- •Patients currently taking nicorandil.
结局指标
主要结局
Haemorrhoidal bleeding
时间窗: 12 months
Evaluated using the French Bleeding Score.
次要结局
- Haemorrhoidal bleeding(1, 3 and 24 months)
- Patient-reported Pain using the Visual Analogue Scale(1 day, 1- and 3-months post treatment, compared to baseline)
- Patient-reported Pain measured by Analgesic intake(1 day, 1- and 3-months post treatment)
- Frequency and severity of procedural complications and other adverse events(Within 3 months after the HAE procedure)
- Functional recovery(From the procedure date until the patient returns to work or usual daily activities (Number of days))
- Freedom from recurrence(1, 3, 12 and 24 months)
- Clinical appearance of haemorrhoids(12 months)
- Patient-reported symptoms(3, 12 and 24 months)
- Patient-reported continence(3 months)
- Patient-reported health-related quality-of-life(1 day, 1-, 3-, 12- and 24-months)
研究者
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