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

Haemorrhoidal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627999
• Other study ID #: OCCaFoncello
• Status: Recruiting
• Start date: January 19, 2023
• Est. completion date: March 20, 2023

Study information

• Verified date: February 2023
• Source: Ospedale Civile Ca' Foncello
• Contact: Giulio Aniello Santoro, MD
• Phone: 00393298854361
• Email: giulioaniello.santoro[@]aulss2.veneto.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 20, 2023
• Est. primary completion date: February 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Haemorrhoidal Bleeding
• Neovascularization, Pathologic

Intervention

Procedure:
• doppler 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.

Locations

Country	Name	City	State
Italy	Ospedale Ca Foncello	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Civile Ca' Foncello

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the reduction in the blood supply	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.	one month
Secondary	correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.		one month