HemorrhoidsNCT05697562
Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
A study testing Rubber band ligatures (RBL), Superior Rectal Artery Embolization (SRAE) and Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL) in people with Hemorrhoids, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Rubber band ligatures (RBL), Superior Rectal Artery Embolization (SRAE) and Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, 1090
Magali Surmont, +32 2 477 ext. 60 11
About this study
Official title: A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
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).
Read the 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).
- Conditions
- Hemorrhoids
- Being tested
- Rubber band ligatures (RBL), Superior Rectal Artery Embolization (SRAE), Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubber band ligatures (RBL)Procedure or surgery
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.
Superior Rectal Artery Embolization (SRAE)Procedure or surgery
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.
Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| anticoagulation group with DG HAL | Placebo comparator | Not described Receives: Procedure: Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL) |
| anticoagulation group with SRAE | Active comparator | Not described Receives: Procedure: Superior Rectal Artery Embolization (SRAE) |
| no anticoagulation group with RBL | Placebo comparator | Not described Receives: Procedure: Rubber band ligatures (RBL) |
| no anticoagulation group with SRAE | Active comparator | Not described Receives: Procedure: Superior Rectal Artery Embolization (SRAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom control
the main objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used
Measured: from baseline to 3 months
Secondary outcomes (7)
Symptom control
a secondary objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used
Measured: 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)
Measured: 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
Measured: from baseline till 12 months
clinical effectiveness
a secondary objective is to report clinical effectiveness, this will be measured using the Goligher score
Measured: 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)
Measured: 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)
Measured: 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
Measured: from baseline till 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided in 2 groups: Anticoagulation group (A) and No Anticoagulation group (NA), based on their regular medication. In both groups, A and NA, are 2 study arms, resp. DG HAL as standard clinical practice versus SRAE (group A) and RBL as standard clinical practice versus SRAE (arm NA). See figure below.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697562
- Sponsor's protocol ID
- HEMbol
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT05697562
- Acronym / sponsor ID
- HEMbol
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients will be divided in 2 groups: Anticoagulation group (A) and No Anticoagulation group (NA), based on their regular medication. In both groups, A and NA, are 2 study arms, resp. DG HAL as standard clinical practice versus SRAE (group A) and RBL as standard clinical practice versus SRAE (arm NA). See figure below.
| Arm | Type | Receives |
|---|---|---|
| anticoagulation group with DG HAL | Placebo comparator | Procedure: Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL) |
| anticoagulation group with SRAE | Active comparator | Procedure: Superior Rectal Artery Embolization (SRAE) |
| no anticoagulation group with RBL | Placebo comparator | Procedure: Rubber band ligatures (RBL) |
| no anticoagulation group with SRAE | Active comparator | Procedure: Superior Rectal Artery Embolization (SRAE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rubber band ligatures (RBL)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. | Procedure or surgery | no anticoagulation group with RBL |
| Superior Rectal Artery Embolization (SRAE)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. | Procedure or surgery | anticoagulation group with SRAE, no anticoagulation group with SRAE |
| Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)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. | Procedure or surgery | anticoagulation group with DG HAL |
Primary outcome
symptom control
Time frame: from baseline to 3 months
the main objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used
7 secondary outcomes
Symptom control
Time frame: from baseline to 12 months
Patient reported effectiveness
Time frame: from baseline till 12 months
Patient reported effectiveness
Time frame: from baseline till 12 months
clinical effectiveness
Time frame: from baseline till 12 months
prevalence of complications
Time frame: from baseline till 12 months
prevalence of re-interventions
Time frame: from baseline till 12 months
prevalence of fecal incontinence
Time frame: from baseline till 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubber band ligatures (RBL), Superior Rectal Artery Embolization (SRAE) and Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL) in people with Hemorrhoids, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali Surmont (+32 2 477 ext. 60 01, magali.surmont@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom control (time frame: from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.