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Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids (HemEmbo)

2026年9月22日 更新者：University of Colorado, Denver

Randomized Phase II Trial of Rectal Artery Embolization Versus Operative Hemorrhoidectomy for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids

This Phase II study will compare rectal artery embolization with operative hemorrhoidectomy in adults with symptomatic bleeding grade 2 and 3 internal hemorrhoids. Participants will be randomly assigned to receive one of the two treatments. The study will evaluate how each treatment affects quality of life, symptom improvement, bleeding control, recovery time, and treatment-related side effects.

The main question this study is trying to answer is whether rectal artery embolization can provide better short-term quality of life compared with surgical hemorrhoidectomy one month after treatment. The study will also examine whether rectal artery embolization allows patients to return to work and normal activities sooner, reduces hemorrhoid-related bleeding, and has a different rate of treatment-related complications compared with surgery.

A total of approximately 102 adult participants will be enrolled at a single academic medical center. The results of this study may help determine whether rectal artery embolization is an effective and less invasive alternative to surgical hemorrhoidectomy for the treatment of bleeding grade 2 and 3 internal hemorrhoids.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

102

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Health
        • 首席研究员：
          • Jonathan Lindquist, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male or female, aged >18 years
  • Goligher grade 2 or 3 internal hemorrhoids not amenable to rubber band ligation in the clinic setting
  • French bleeding score > 5
  • Rectal bleeding greater than 3 months
  • Colonoscopy within three years, negative for colorectal malignancy
  • INR < 1.5
  • Platelet count > 150,000/dL
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after intervention
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

  • Current use of anticoagulants and/or DAPT
  • Presence of vascular disease or previous vascular intervention preventing endovascular access to the rectal arteries
  • Prior surgical or endovascular treatment of hemorrhoids
  • Prior endoscopic hemorrhoid artery ligation
  • Pregnancy or lactation
  • Known severe allergic reactions to iodinated contrast not mitigated by standard prophylaxis
  • Bleeding attributable to other anorectal pathology such as anal fissures, anorectal abscess, or fistula
  • Inflammatory bowel disease
  • Inflammatory vasculitis or connective tissue disease
  • Current participation in another clinical trial which may interfere with participation in this study
  • Treatment with bevacizumab within 2 months
  • Contraindication to surgical management of internal hemorrhoids
  • Primary or secondary malignancy involving the abdomen or pelvis which is likely to impact treatment
  • Prior pelvic radiation therapy
  • Prior diagnosis of portal hypertension
  • Major comorbidities expected to impact outcomes or increase patient risk, in the judgement of the enrolling physician

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Rectal Artery Embolization

Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.
程序：Rectal Artery Embolization

A minimally invasive procedure in which a doctor uses imaging guidance to place a small catheter into an artery and injects embolization materials to block the blood vessels supplying the hemorrhoids. This reduces blood flow and helps shrink the hemorrhoids.
有源比较器：Operative Hemorrhoidectomy

Participants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.
程序：Operative Hemorrhoidectomy

A surgical procedure performed under anesthesia in which the surgeon removes or excises the hemorrhoidal tissue. This is the current standard treatment for severe hemorrhoids.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Quality of Life Following Treatment
大体时间：Baseline and 1 month after treatment

Comparison of quality-of-life, as measured by the Short Health Scale for Hemorrhoid Disease, 1 month following superior rectal artery embolization and open surgical hemorrhoidectomy. Scores range from 4 to 28, with lower scores indicating better quality of life and higher scores indicating worse quality of life.
Baseline and 1 month after treatment

次要结果测量

结果测量
措施说明
大体时间
Time to Return to Work
大体时间：From treatment through return to work or normal activities, up to 6 months after treatment

Comparison of time to return to work following superior rectal artery embolization and open surgical hemorrhoidectomy.
From treatment through return to work or normal activities, up to 6 months after treatment
Time to Return to Pre-Intervention Activities
大体时间：From treatment until return to pre-intervention activities, up to 6 months after treatment

Comparison of time to return to pre-intervention activities following superior rectal artery embolization and open surgical hemorrhoidectomy as measured by selected elements of the adapted VEINES questionnaire. Scores range from 3 to 12, with higher scores indicating less limitation in daily, social, and leisure activities and therefore better functional recovery. Lower scores indicate greater activity limitation and poorer functional recovery.
From treatment until return to pre-intervention activities, up to 6 months after treatment
Achievement of French Bleeding Score <2
大体时间：6 months after treatment

Comparison of proportion of patients that achieve French Bleeding Scores < 2 following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids. For the French Bleeding Score, total scores range from 0 to 9, with lower scores indicating less bleeding and better clinical outcomes, and higher scores indicating more severe hemorrhoidal bleeding and worse clinical outcomes.
6 months after treatment
Treatment-Related Adverse Events
大体时间：From treatment through 6 months after treatment

Comparison of adverse events following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids.
From treatment through 6 months after treatment

其他结果措施

结果测量
措施说明
大体时间
Correlation of Rectal Arterial Anatomy With Clinical Outcomes
大体时间：Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.

Evaluate number and size of arteries and correlate with observed outcomes.
Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Colorado, Denver

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月19日

初级完成 (估计的)

2028年10月19日

研究完成 (估计的)

2028年10月19日

研究注册日期

首次提交

2026年9月22日

首先提交符合 QC 标准的

2026年9月22日

首次发布 (实际的)

2026年9月28日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 25-0192

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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