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Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.

Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05627999
Enrollment
10
Registered
2022-11-28
Start date
2023-01-19
Completion date
2023-03-20
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemorrhoidal Bleeding

Brief summary

To evaluate the usefulness of endoanal ultrasound in the evaluation of emorrhoidal artery embolization outcomes

Detailed description

Haemorrhoidal artery embolization (Emborrhoid) is a novel method for the treatment of haemorrhoids. Through the catheterization of the femoral artery and a selective angiogram of the inferior mesenteric artery, embolic agents are delivered to occlude the SRA. Despite the technical success rate has been reported to reach 93%-100%, clinical success ranges between 63% and 94% with rebleeding occurring in 13.6% of cases due to the presence of a significant MRA in 24% of cases \[BIBLIO} . There is no data in the literature on how the arterial flow changes after the treatment. The primary aim of the present study was to assess the reduction in the blood supply by comparing the hemorrhoidal arterial systolic peak before and after Hemborrhoid by using endoanal ultrasound (EAUS) combined with doppler. The secondary aim was to evaluate if a relation exists between the reduction and the efficacy of this treatment by the Hemorrhoidal Bleeding Score.

Interventions

PROCEDUREdoppler endoanal ultrasound

The primary aim was to assess the reduction in the blood supply by comparing the hemorrhoidal arterial systolic peak (overall and sectorial) before and after Emborrhoid.

Sponsors

Ospedale Civile Ca' Foncello
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* symptomatic hemorrhoidal disease (French bleeding score \[FBS\] \> 4), Goligher's classification score II or III, age \>18 years, failure of non-operative management (change life style, dietary modification, supplemental fibers for constipation, over-the-counter treatments).

Exclusion criteria

* age \< 18 years, Goligher prolapse score IV, pregnancy, previous haemorrhoidal surgery, inflammatory bowel disease.

Design outcomes

Primary

MeasureTime frameDescription
the reduction in the blood supplyone monthThe primary aim was to assess the reduction in the blood supply by comparing the hemorrhoidal arterial systolic peak (overall and sectorial) before and after Emborrhoid.

Secondary

MeasureTime frame
correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.one month

Countries

Italy

Contacts

Primary ContactGiulio Aniello Santoro, MD
giulioaniello.santoro@aulss2.veneto.it00393298854361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026