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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
UZ Brussel
RECRUITING
Jette
Contact Information
Primary
Magali Surmont
magali.surmont@uzbrussel.be
+32 2 477
Backup
Virgini Van Buggenhout
virgini.vanbuggenhout@uzbrussel.be
+32 2 477
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 80
Treatments
Placebo_comparator: anticoagulation group with DG HAL
Active_comparator: anticoagulation group with SRAE
Placebo_comparator: no anticoagulation group with RBL
Active_comparator: no anticoagulation group with SRAE
Related Therapeutic Areas
Sponsors
Leads: Universitair Ziekenhuis Brussel

This content was sourced from clinicaltrials.gov