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Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

ConditionHemorrhoids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rubber band ligatures (RBL)

    Procedure/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/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/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.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: anticoagulation group with DG HALPlacebo comparator 1 intervention
Group B: anticoagulation group with SRAEActive comparator 1 intervention
Group C: no anticoagulation group with RBLPlacebo comparator 1 intervention
Group D: no anticoagulation group with SRAEActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitair Ziekenhuis Brussel

Lead sponsor

Source ClinicalTrials.gov
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