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Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Primary Purpose

Hemorrhoids

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rubber band ligatures (RBL)
Superior Rectal Artery Embolization (SRAE)
Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    anticoagulation group with DG HAL

    anticoagulation group with SRAE

    no anticoagulation group with RBL

    no anticoagulation group with SRAE

    Arm Description

    Outcomes

    Primary Outcome Measures

    symptom control
    the main objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used

    Secondary Outcome Measures

    Symptom control
    a secondary objective is to control the symptoms, for this the Hemorrhoidal Bleeding Score is to be used
    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)
    Patient reported effectiveness
    a secondary objective is to report patient effectiveness, this will be measured using the 5-level EQ-5D-5L score
    clinical effectiveness
    a secondary objective is to report clinical effectiveness, this will be measured using the Goligher score
    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)
    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)
    prevalence of fecal incontinence
    a secondary objective is to report the prevalence of fecal incontinence, this will be measured using the Jorge-wexner score

    Full Information

    First Posted
    December 21, 2022
    Last Updated
    January 24, 2023
    Sponsor
    Universitair Ziekenhuis Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05697562
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    December 15, 2025 (Anticipated)
    Study Completion Date
    December 15, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitair Ziekenhuis Brussel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemorrhoids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    anticoagulation group with DG HAL
    Arm Type
    Placebo Comparator
    Arm Title
    anticoagulation group with SRAE
    Arm Type
    Active Comparator
    Arm Title
    no anticoagulation group with RBL
    Arm Type
    Placebo Comparator
    Arm Title
    no anticoagulation group with SRAE
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Rubber band ligatures (RBL)
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Superior Rectal Artery Embolization (SRAE)
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    symptom control
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Symptom control
    Description
    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
    Title
    Patient reported effectiveness
    Description
    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
    Title
    Patient reported effectiveness
    Description
    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
    Title
    clinical effectiveness
    Description
    a secondary objective is to report clinical effectiveness, this will be measured using the Goligher score
    Time Frame
    from baseline till 12 months
    Title
    prevalence of complications
    Description
    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
    Title
    prevalence of re-interventions
    Description
    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
    Title
    prevalence of fecal incontinence
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Magali Surmont
    Phone
    +32 2 477
    Ext
    60 01
    Email
    magali.surmont@uzbrussel.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Virgini Van Buggenhout
    Phone
    +32 2 477
    Ext
    50 14
    Email
    virgini.vanbuggenhout@uzbrussel.be

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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