STRATOS: Single-center Randomized Controlled Trial of Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
Jessica K. Stewart, MD
Summary
The purpose of this clinical trial is to compare two standard of care non-surgical treatments for hemorrhoidal bleeding: hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL). Directly comparing these two methods may help to clarify which treatment is better for controlling hemorrhoidal bleeding, reducing symptoms, and improving patients' quality of life. HAE is a standard minimally invasive procedure to put tiny particles or coils into the blood vessel that feeds a hemorrhoid to block the blood flow (embolization). This involves using a catheter inserted into an artery, using twilight (conscious) sedation. RBL is a standard procedure that involves using small rubber bands around the base of the hemorrhoids to cut off blood flow, causing it to shrink or shrivel.
Description
A single center, prospective, open-label, double arm, randomized trial to compare rates of control of bleeding from hemorrhoids, during prospective follow-up in patients with internal hemorrhoids undergoing hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL), and the number of procedures needed for hemostasis. Subjects will be considered enrolled in the study once they have provided informed consent. They will then be randomized to one of two arms after completion of the in-person screening visit. Subjects may proceed to the procedure visit after they have met all screeni…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years and less than 90 years. 2. Ability to provide written informed consent. 3. Documented clinical history of chronic bleeding from internal hemorrhoids. 4. Documented presence of Goligher grade II-III internal hemorrhoids. 5. Failed conservative treatment for bleeding hemorrhoids (e.g. fiber supplementation, topical ointments and creams, dietary modifications, stool softeners, warm baths). 6. Able to comply with all treatments and protocol follow-up visits, in the opinion of the PI's. Exclusion Criteria: 1. Moderate loss of kidney function, defined as esti…
Interventions
- DeviceHemorrhoidal Artery Embolization
Involves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it.
- ProcedureRubber Band Ligation
Involves using a band to cut off blood flow to the hemorrhoid and shrink it.
Location
- Ronald Reagan UCLA Medical CenterLos Angeles, California