RecruitingNot ApplicableNCT05697562

Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Sponsor

Universitair Ziekenhuis Brussel

Enrollment

80 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Hemorrhoids

Summary

SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials. A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD. Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery. Furthermore, DG-HAL and RBL are equally effective procedures. The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates superior rectal artery embolization (SRAE) — a minimally invasive, non-surgical procedure — for treating hemorrhoidal disease with significant bleeding. Hemorrhoids are enlarged blood vessels in and around the rectum that can bleed, cause pain, and significantly impact quality of life. SRAE uses a catheter to block part of the blood supply to hemorrhoids, causing them to shrink, without requiring traditional surgery or anesthesia. This trial tests its safety and effectiveness for Grade I–III hemorrhoidal disease. You may be eligible if: - You are over 18 years old - You have Grade I–III hemorrhoidal disease with rectal bleeding as the main symptom - Your Hemorrhoid Bleeding Score (HBS) is 5 or higher - You can read Dutch, French, or English - You have or have not had prior non-surgical treatments for hemorrhoids You may NOT be eligible if: - Your hemorrhoids are Grade IV (permanent prolapse) - You have rectal prolapse - You have had previous surgical treatment for hemorrhoids - You have acute hemorrhoidal thrombosis or perianal hematoma - You have anal stenosis, anal fissure, or inflammatory bowel disease - You have a history of colorectal or anal cancer - You have portal hypertension (Child-Pugh Class C liver disease) - You are pregnant - You are allergic to iodinated contrast agents (used in the procedure) - Colonoscopy has not ruled out other causes of bleeding in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERubber band ligatures (RBL)

This instrumental technique is realized during consultation. A rubber band is applied on top of each hemorrhoidal complex via a proctoscope. This banding causes an ulceration which heals with resulting fibrosis. The patient can receive a maximum of 3 RBL during each session, which can be repeated up to 3 times at a 6 weeks interval.

PROCEDURESuperior Rectal Artery Embolization (SRAE)

This technique is realized under local anesthesia during a one-day hospitalization. The interventional radiologist will perform the procedure in the angiography room. After local anesthesia right femoral artery puncture is performed and a 4 F or 5 F introducer sheath is placed using the Seldinger technique. With an appropriate 4 or 5 F catheter the superior rectal artery is catheterized. With a microcatheter the different branches are selectively occluded with microcoils. The endpoint of embolization is reached when all SRA branches above the pubic ramus are embolized, with cessation of flow distally or a static column of contrast. The procedure can be repeated with addition of the embolization of the middle rectal wall artery (MRA) in case of failure after 12 weeks.

PROCEDUREDoppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)

The procedure is performed in lithotomy position with a modified proctoscope including a Doppler transducer (THD device) under anesthesia during a one-day hospitalization. This transanal Doppler guidance enables accurate detection and targeted suture ligation of the SRAs Following gel lubrication, the proctoscope is inserted through the anal canal reaching the low rectum, about 6-7 cm from the anal verge. After identification of the best place for artery ligation, the Doppler system is turned off. The artery will be directly ligated with a Z-stitch at the site of the best Doppler signal.

Locations(1)

UZ Brussel

Jette, Belgium

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