Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Not Applicable

Recruiting

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

• Registration Number: NCT05697562
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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).

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 Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-26
• Study Start: 2023-06-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-03
• Primary Completion: 2025-12-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no anticoagulation group with RBL	Rubber band ligatures (RBL)	-
anticoagulation group with SRAE	Superior Rectal Artery Embolization (SRAE)	-
anticoagulation group with DG HAL	Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)	-
no anticoagulation group with SRAE	Superior Rectal Artery Embolization (SRAE)	-

Primary Outcome Measures

Name	Time	Method
symptom control	from baseline to 3 months	the main objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used

Secondary Outcome Measures

Name	Time	Method
prevalence of fecal incontinence	from baseline till 12 months	a secondary objective is to report the prevalence of fecal incontinence, this will be measured using the Jorge-wexner score
Symptom control	from baseline to 12 months	a secondary objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used
prevalence of re-interventions	from baseline till 12 months	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)
Patient reported effectiveness	from baseline till 12 months	a secondary objective is to report patient effectiveness, this will be measured using the 5-level EQ-5D-5L score
prevalence of complications	from baseline till 12 months	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)
clinical effectiveness	from baseline till 12 months	a secondary objective is to report clinical effectiveness, this will be measured using the Goligher score

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium