Clinical trial NCT05697562: Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
Official title: A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: Inclusion Criteria:

* 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

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 or perianal hematoma)
* Anal stenosis, congenital of acquired
* Chronic anal fissure
* 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)

Primary outcomes:
measure: symptom control
timeFrame: from baseline to 3 months
Secondary outcomes:
measure: Symptom control
timeFrame: from baseline to 12 months
measure: Patient reported effectiveness
timeFrame: from baseline till 12 months
measure: Patient reported effectiveness
timeFrame: from baseline till 12 months
measure: clinical effectiveness
timeFrame: from baseline till 12 months
measure: prevalence of complications
timeFrame: from baseline till 12 months
measure: prevalence of re-interventions
timeFrame: from baseline till 12 months
measure: prevalence of fecal incontinence
timeFrame: from baseline till 12 months
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
References: