Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

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

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).

Study Overview

• Status: Recruiting
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL); Procedure: Superior Rectal Artery Embolization (SRAE); Procedure: Rubber band ligatures (RBL)

Detailed Description

Hemorrhoidal disease (HD) is the most common anorectal pathology. Therapeutic management of HD ranges from conservative treatment and instrumental treatment to surgical approach. Beside these, certain minimally invasive techniques such as radiofrequency ablation, laser coagulation and Superior Rectal Artery Embolization (SRAE) are gaining interest. 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).

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virgini Van Buggenhout; Phone Number: 50 14 +32 2 477; Email: virgini.vanbuggenhout@uzbrussel.be
• Study Contact Backup: Name: Magali Surmont; Phone Number: 60 01 +32 2 477; Email: magali.surmont@uzbrussel.be

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Magali Surmont; Phone Number: 60 11 +32 2 477

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients referred for Hemorrhoidal disease with bleeding are eligible. Significant bleeding is defined as a HBS of ≥ 5.
• Age > 18 years old;
• Sexes eligible for study: all
• Hemorrhoidal disease grade I-III according the Goligher classification with rectal bleeding as predominant symptom
• History of prior instrumental treatment of HD does not prohibit inclusion
• Able to understand and read Dutch, French or English

Exclusion Criteria:

• Permanent hemorrhoidal prolapse/grade IV hemorrhoidal disease
• Rectal prolapse
• History of proctological surgery for HD
• Acute complicated course of HD i.e. acute thrombosis (fluxio hemorrhoidalis or perianal hematoma)
• Anal stenosis, congenital of acquired
• Chronic anal fissure
• Active rectal inflammation, including peri-anal abscess (e.g. Inflammatory Bowel Disease, infectious,…)
• History of colorectal or anal cancer
• History of rectal or sigmoidal resection
• Portal hypertension and liver cirrhosis Child Pugh C
• Radiation rectitis
• Neurological disease involving anal sphincter musculature
• Severe psychiatric disorder
• Pregnancy
• Allergy to iodinated contrast agents
• Colorectal neoplasia as the cause of bleeding (excluded with a (virtual) colonoscopy in the last year)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: anticoagulation group with DG HAL	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.
Active Comparator: anticoagulation group with SRAE	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.
Placebo Comparator: no anticoagulation group with RBL	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.
Active Comparator: no anticoagulation group with SRAE	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptom control	the main objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used	from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom control	a secondary objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used	from baseline to 12 months
Patient reported effectiveness	a secondary objective is to report patient effectiveness, this will be measured using Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction score (PROM-HISS)	from baseline till 12 months
Patient reported effectiveness	a secondary objective is to report patient effectiveness, this will be measured using the 5-level EQ-5D-5L score	from baseline till 12 months
clinical effectiveness	a secondary objective is to report clinical effectiveness, this will be measured using the Goligher score	from baseline till 12 months
prevalence of complications	a secondary objective is to report the prevalence of complications, this will be measured using among others the pain score reported by Visual Analogue Scale (VAS)	from baseline till 12 months
prevalence of re-interventions	a secondary objective is to report the prevalence of re-interventions, this will be measured among others with the pain score reported by Visual Analogue Scale (VAS)	from baseline till 12 months
prevalence of fecal incontinence	a secondary objective is to report the prevalence of fecal incontinence, this will be measured using the Jorge-wexner score	from baseline till 12 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: HEMbol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No