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

NCT07844629 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 25-0192
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhoids Internal; Hemorrhoids Second Degree; Hemorrhoids Third Degree

Outcome Measures

Primary Outcomes (1)

• Quality of Life Following 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 Outcomes (4)

• Time to Return to Work

  From treatment through return to work or normal activities, up to 6 months after treatment

• Time to Return to Pre-Intervention Activities

  From treatment until return to pre-intervention activities, up to 6 months after treatment

• Achievement of French Bleeding Score <2

  6 months after treatment

• Treatment-Related Adverse Events

  From treatment through 6 months after treatment

Other Outcomes (1)

• Correlation of Rectal Arterial Anatomy With Clinical Outcomes

  Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.

Study Arms (2)

Rectal Artery Embolization

EXPERIMENTAL

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

Procedure: Rectal Artery Embolization

Operative Hemorrhoidectomy

ACTIVE COMPARATOR

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

Procedure: Operative Hemorrhoidectomy

Interventions

Rectal Artery Embolization PROCEDURE

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.

Rectal Artery Embolization

Operative Hemorrhoidectomy PROCEDURE

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.

Operative Hemorrhoidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Health

Aurora, Colorado, 80045, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with symptomatic bleeding Goligher grade 2 or 3 internal hemorrhoids will be randomly assigned in a 1:1 ratio to undergo either rectal artery embolization or operative hemorrhoidectomy. The two treatment groups will be followed in parallel and compared with respect to quality of life, return to work and normal activities, bleeding outcomes, and treatment-related adverse events.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): October 19, 2028
• Study Completion (Estimated): October 19, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

US (1)