Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of procedure related mortality (safety)
研究概览
简要总结
In this study , safety and efficacy of superior rectal artery embolization with embospheres will be researched prospectively.
详细描述
Symptomatic hemorrhoidal disease is a still important public health problem although there are many surgical and nonsurgical minimal invasive treatment methods. Treatment methods are not satisfactory or invasive in some percent of the patients. Superior rectal artery embolization(SRAE) for hemorrhoids is an adapted technique derived from Doppler-guided hemorrhoidal artery ligation (DGHAL). In this technique, the distal branches of the superior rectal artery arising from the inferior mesenteric artery is occluded endovascularly with coils. Its feasibility and safety were supported by articles. Collateralization and recurrence was seen following coil embolization. To prevent this , tri-acryl gelatin microspheres in 500-700 and 700-900 micrometers in size will be used. Safety and efficacy of embolization and using different sized particles will be evaluated.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptoms of hemorrhoidal disease
- •Patients with written informed consent
- •Patients refusing surgery or other interventional methods
- •Patients with high risk for surgery
- •Patients accepting follow ups
排除标准
- •Previous intervention
- •Colorectal diseases other than hemorrhoids
- •Patients with anal stenosis
- •Patients with rectal prolapsus
- •pregnant patients
- •Patients with contraindications for technical steps or contrast usage.
- •Patients do nor or could not give written informed consent
研究组 & 干预措施
Embospheres 500-700 microns
Intervention.Embolization with 500-700 micron particles will be performed with 1 ml vials. Embolization procedure will be continued with vials until the stasis in SRAE will be achieved. Procedure will be performed only one time.
干预措施: Embolization with tri-acryl gelatin (Embosphere) particles (Device)
Embospheres 700-900 microns
Intervention.Embolization with 700-900 micron particles will be performed with 1 ml vials. Embolization procedure will be continued with vials until the stasis in SRAE will be achieved. Procedure will be performed only one time.
干预措施: Embolization with tri-acryl gelatin (Embosphere) particles (Device)
结局指标
主要结局
Incidence of procedure related mortality (safety)
时间窗: 12 month
The mortality rate among the patients during 12 months related with interventional procedure.
Incidence of procedure related complications (safety)
时间窗: 12 month
The morbidity rate among the patients during 12 months related with interventional procedure.
Incidence of the patients' being free of symptoms from hemorrhoidal disease (efficacy)
时间窗: 12 month
The efficacy and clinical success of the procedure will be evaluated
次要结局
- Technical success(On the day of intervention)
- Recurrence(3-6-12. months)
研究者
Fahrettin Kucukay,MD
Prof.Dr.
Eskisehir Osmangazi University