Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
ConditionHemorrhoids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Rubber band ligatures (RBL)
- Superior Rectal Artery Embolization (SRAE)
- Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov