Hemorrhoidal Embolization Trial-1 (HEMBO-1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of pre-embolization Computed Tomography Angiography (CTA)
研究概览
简要总结
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
详细描述
This is a prospective, single-arm, single center phase I/IIa observational study to systematically investigate outcomes and quality of life in patients with grade II or III bleeding predominant internal hemorrhoids referred to Vascular and Interventional Radiology (VIR) by Colorectal Surgery (CRS) for clinically indicated rectal artery embolization. 20 adult patients who meet the inclusion and exclusion criteria will be consented and enrolled in the study.
During the study, the subject will undergo 6 study visits, one before and five after their clinical rectal artery embolization procedure. Patients referred from the Colorectal Surgery Clinic who are scheduled to undergo rectal artery embolization (RAE) as part of standard clinical care will be enrolled. Baseline anoscopy and clinical evaluation will be performed per standard clinical care in the Colorectal Surgery Clinic and baseline patient reported outcomes and quality of life questionnaires administered. A research pelvis CTA will be performed on a clinical CT scanner per standard clinical imaging protocol for assessment of the rectal arteries prior to embolization. Following rectal artery embolization, subjects will undergo a day 1 post-procedure clinical evaluation in Interventional Radiology followed by repeat anoscopy and clinical evaluation per standard clinical care in the Colorectal Surgery Clinic as well as repeat patient reported outcomes and quality of life questionnaires at 1, 3, 6 and 12 months post rectal artery embolization with a clinical research study coordinator in Vascular and Interventional Radiology, either in person or virtually (video or phone).
The aims of the study are:
Aim 1. To determine the 12-month efficacy of rectal artery embolization with particles + coils for treatment of symptomatic bleeding predominant hemorrhoidal disease
Aim 2. To determine the 12-month safety of rectal artery embolization with particles + coils for treatment of symptomatic bleeding predominant hemorrhoidal disease.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade II or III hemorrhoidal disease as determined by a board-certified colorectal surgeon.
- •Persistent or recurrent symptoms following hygiene and dietary measures or medication.
- •Bleeding predominant ± pain symptoms.
- •Undergoing planned rectal artery embolization (RAE) per standard clinical care.
- •Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent.
- •Negative pregnancy test (if applicable).
排除标准
- •Prior hemorrhoid surgery.
- •Grade IV hemorrhoidal disease.
- •Acute hemorrhoid complications.
- •Chronic anal or perianal fissures.
- •History of colorectal surgery or pelvic radiation.
- •Inflammatory bowel disease.
- •Portal hypertension or mesenteric venous congestion/occlusion.
- •Inferior mesenteric artery (IMA) or internal iliac artery (IIA) stenosis or occlusion.
- •Contraindication to iodinated contrast.
- •Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure per clinical care.
结局指标
主要结局
Diagnostic accuracy of pre-embolization Computed Tomography Angiography (CTA)
时间窗: Baseline (pre-embolization)
Diagnostic accuracy and inter-rater agreement of pre-embolization CTA in identifying the hemorrhoidal arteries supplying the hemorrhoidal cushion
Adverse Events
时间窗: Day 1 and 1, 3, 6 and 12 months
Number of subjects to experience adverse events defined by 1) Common Terminology Criteria for Adverse Events (CTCAE) v6.0, 2) Society of Interventional Radiology \[SIR\] classifications of postoperative complications and 3) Clavien-Dindo Classification
Change in French bleeding score (FBS)
时间窗: Baseline, 1, 3, 6 and 12 months
The French bleeding score assesses the intensity of hemorrhoidal bleeding with scores ranging from 0 (no bleeding) to 9 (daily bleeding with anemia requiring blood transfusions)
次要结局
- Goligher Prolapse Score(Baseline, 1, 3, 6 and 12 months)
- Brief Pain Inventory (BPI) Short Form(Baseline, 1, 3, 6 and 12 months)
- Visual Analog Scale (VAS) for Quality of Life(Baseline, 1, 3, 6 and 12 months)
- Hemorrhoidal Bleeding Score (HBS)(Baseline, 1, 3, 6 and 12 months)
- Visual Analog Scale (VSS) Pain(Baseline, 1, 3, 6 and 12 months)
- Hemorrhoidal Severity Score (HSS)(Baseline, 1, 3, 6 and 12 months)
- Vaizey Incontinence Score(Baseline, 1, 3, 6 and 12 months)
研究者
Scott M. Thompson
Principal Investigator
Mayo Clinic