A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- symptom control
研究概览
简要总结
SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials. A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD.
Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery. Furthermore, DG-HAL and RBL are equally effective procedures. The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study).
详细描述
Hemorrhoidal disease (HD) is the most common anorectal pathology. Therapeutic management of HD ranges from conservative treatment and instrumental treatment to surgical approach. Beside these, certain minimally invasive techniques such as radiofrequency ablation, laser coagulation and Superior Rectal Artery Embolization (SRAE) are gaining interest. SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials. A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD. Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery. Furthermore, DG-HAL and RBL are equally effective procedures. The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study).
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
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
- •All patients referred for Hemorrhoidal disease with bleeding are eligible. Significant bleeding is defined as a HBS of ≥
- •Age > 18 years old;
- •Sexes eligible for study: all
- •Hemorrhoidal disease grade I-III according the Goligher classification with rectal bleeding as predominant symptom
- •History of prior instrumental treatment of HD does not prohibit inclusion
- •Able to understand and read Dutch, French or English
排除标准
- •Permanent hemorrhoidal prolapse/grade IV hemorrhoidal disease
- •Rectal prolapse
- •History of proctological surgery for HD
- •Acute complicated course of HD i.e. acute thrombosis (fluxio hemorrhoidalis or perianal hematoma)
- •Anal stenosis, congenital of acquired
- •Chronic anal fissure
- •Active rectal inflammation, including peri-anal abscess (e.g. Inflammatory Bowel Disease, infectious,…)
- •History of colorectal or anal cancer
- •History of rectal or sigmoidal resection
- •Portal hypertension and liver cirrhosis Child Pugh C
- •Radiation rectitis
- •Neurological disease involving anal sphincter musculature
- •Severe psychiatric disorder
- •Pregnancy
- •Allergy to iodinated contrast agents
- •Colorectal neoplasia as the cause of bleeding (excluded with a (virtual) colonoscopy in the last year)
结局指标
主要结局
symptom control
时间窗: from baseline to 3 months
the main objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used
次要结局
- prevalence of fecal incontinence(from baseline till 12 months)
- Symptom control(from baseline to 12 months)
- prevalence of re-interventions(from baseline till 12 months)
- prevalence of complications(from baseline till 12 months)
- clinical effectiveness(from baseline till 12 months)
- Patient reported effectiveness(from baseline till 12 months)