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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07844629
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hemorrhoids Internal
  • Hemorrhoids Second Degree
  • Hemorrhoids Third Degree

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Sep 28, 2026
Start date
Oct 19, 2026
Status verified
Sep 2026
Primary completion
Oct 19, 2028
Completion
Oct 19, 2028

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rectal Artery Embolization
    Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.
  • Active Comparator: Operative Hemorrhoidectomy
    Participants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.

Primary Outcome Measure

Quality of Life Following Treatment [ Time Frame: Baseline and 1 month after treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HealthAuroraColorado80045
Alejandra Aguilar, MPH, CCRP, CPH
7208486612
Jonathan Lindquist, MD (PRINCIPAL_INVESTIGATOR)

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