An interventional study of Rubber band ligatures (RBL) and Superior Rectal Artery Embolization (SRAE) in Hemorrhoids, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment
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).
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).
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.
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A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)
Procedure: Superior Rectal Artery Embolization (SRAE)
Procedure: Rubber band ligatures (RBL)
Procedure: Superior Rectal Artery Embolization (SRAE)
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.
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.
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.
symptom control
the main objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used
Time frame: from baseline to 3 months
Symptom control
a secondary objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used
Time frame: 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)
Time frame: 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
Time frame: from baseline till 12 months
clinical effectiveness
a secondary objective is to report clinical effectiveness, this will be measured using the Goligher score
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: from baseline till 12 months
Plan to share: No
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Started Jun 2023 (actual). Primary completion is estimated for Dec 2030, 90 months after the start.
Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 90 months is above that.
Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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