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

September 22, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health
        • Principal Investigator:
          • Jonathan Lindquist, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rectal Artery Embolization

Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.
Procedure: 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.
Active Comparator: Operative Hemorrhoidectomy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Following Treatment
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Return to Work
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Rectal Arterial Anatomy With Clinical Outcomes
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 19, 2026

Primary Completion (Estimated)

October 19, 2028

Study Completion (Estimated)

October 19, 2028

Study Registration Dates

First Submitted

September 22, 2026

First Submitted That Met QC Criteria

September 22, 2026

First Posted (Actual)

September 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 28, 2026

Last Update Submitted That Met QC Criteria

September 22, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 25-0192

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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