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NOT YET RECRUITING
NCT07844629
PHASE2

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2026-10-19

Completion Date

2028-10-19

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

University of Colorado Health

Aurora, Colorado, United States