Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

December 15, 2025

Study Completion Date

December 15, 2026

Conditions
Hemorrhoids
Interventions
PROCEDURE

Rubber 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.

PROCEDURE

Superior 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."

PROCEDURE

Doppler-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.

Trial Locations (1)

1090

RECRUITING

UZ Brussel, Jette

All Listed Sponsors
lead

Universitair Ziekenhuis Brussel

OTHER