Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Last updated: April 30, 2024
Sponsor: Universitair Ziekenhuis Brussel
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhoids

Treatment

Rubber band ligatures (RBL)

Superior Rectal Artery Embolization (SRAE)

Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)

Clinical Study ID

NCT05697562
HEMbol
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • All patients referred for Hemorrhoidal disease with bleeding are eligible. Significantbleeding 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 rectalbleeding as predominant symptom
  • History of prior instrumental treatment of HD does not prohibit inclusion
  • Able to understand and read Dutch, French or English

Exclusion

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 orperianal hematoma)
  • Anal stenosis, congenital of acquired
  • Chronic anal fissure
  • Active rectal inflammation, including peri-anal abscess (e.g. Inflammatory BowelDisease, 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) colonoscopyin the last year)

Study Design

Total Participants: 80
Treatment Group(s): 3
Primary Treatment: Rubber band ligatures (RBL)
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
December 15, 2026

Study 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).

Connect with a study center

  • UZ Brussel

    Jette, 1090
    Belgium

    Active - Recruiting

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