Pilot Study of the Safety and Efficacy of Trans-radial Superior Rectal Artery Embolisation for the Treatment of Haemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and long-term effects
研究概览
简要总结
Endovascular embolisation is already a common procedure for bleeding haemorrhoids in the acute setting, where surgical options are not possible or have been exhausted. This pilot study aims to add to the small body of evidence that transarterial embolisation of symptomatic haemorrhoids is also safe and effective in the elective setting, providing a good alternative to conventional surgical management. This is a day case procedure that is performed under local anaesthetic. For selected patients, this presents a less invasive management option with reduced potential morbidity. For a health care system under significant financial stress, this provides a potential means of cost improvement, the extent of which this study will try and quantify. A series of 20 selected patients will be recruited to undergo this procedure and then followed up for 24 months. The long-term goal of this pilot study is to form the basis of a national registry of such procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients eligible for the study must comply with all of the following prior to enrolment:
- •Patients with grade II-IV haemorrhoid disease with re-current or active bleeding
- •Patients with (i) who do not wish to undergo surgery for their symptoms
- •Patients with (i) despite recent surgery
- •Patients willing and able to give fully informed consent
- •Patients aged ≥18 years
排除标准
- •Patients who are not otherwise fit for surgery
- •Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses)
- •Patient who are unable to sign the informed consent form.
- •Patients who are pregnant (completed as part of standard IRMER protocol)
- •Patients with history of significant colorectal disease or previous colectomy.
- •Patients with history of an allergic reaction to x-ray contrast
- •Patients who are currently involved in research
结局指标
主要结局
Safety and long-term effects
时间窗: 3 years
Safety and efficacy of the haemorrhoid embolisation procedure in relation to the rate of immediate and long-term complications
次要结局
- Contrast volume comparison(3 years)
- Change of symptoms(24 months)
- Cost comparison(3 years)
- Procedural times comparison(3 years)
- Radiation dose comparison(3 years)