Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- the reduction in the blood supply
研究概览
简要总结
To evaluate the usefulness of endoanal ultrasound in the evaluation of emorrhoidal artery embolization outcomes
详细描述
Haemorrhoidal artery embolization (Emborrhoid) is a novel method for the treatment of haemorrhoids. Through the catheterization of the femoral artery and a selective angiogram of the inferior mesenteric artery, embolic agents are delivered to occlude the SRA. Despite the technical success rate has been reported to reach 93%-100%, clinical success ranges between 63% and 94% with rebleeding occurring in 13.6% of cases due to the presence of a significant MRA in 24% of cases [BIBLIO} . There is no data in the literature on how the arterial flow changes after the treatment.
The primary aim of the present study was to assess the reduction in the blood supply by comparing the hemorrhoidal arterial systolic peak before and after Hemborrhoid by using endoanal ultrasound (EAUS) combined with doppler. The secondary aim was to evaluate if a relation exists between the reduction and the efficacy of this treatment by the Hemorrhoidal Bleeding Score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic hemorrhoidal disease (French bleeding score [FBS] > 4), Goligher's classification score II or III, age >18 years, failure of non-operative management (change life style, dietary modification, supplemental fibers for constipation, over-the-counter treatments).
排除标准
- •age < 18 years, Goligher prolapse score IV, pregnancy, previous haemorrhoidal surgery, inflammatory bowel disease.
结局指标
主要结局
the reduction in the blood supply
时间窗: one month
The primary aim was to assess the reduction in the blood supply by comparing the hemorrhoidal arterial systolic peak (overall and sectorial) before and after Emborrhoid.
次要结局
- correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.(one month)
研究者
Giulio Aniello Santoro
Surgeon
Ospedale Civile Ca' Foncello