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

Recruiting

• Conditions: Haemorrhoidal Bleeding
• Interventions: Procedure: doppler endoanal ultrasound

• Registration Number: NCT05627999
• Lead Sponsor: Ospedale Civile Ca' Foncello

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.

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-28
• Study Start: 2023-01-19
• Status Verified: 2023-02
• Primary Completion: 2023-02-19
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27
• Study Completion: 2023-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients candidate to the haemorrhoidal artery embolization	doppler endoanal ultrasound	Consecutive patients assessed at the Division of General Surgery 1, Treviso Regional Hospital, from October to December 2021 and candidate to the haemorrhoidal artery embolization were included in the study. Indications to the procedure were 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). Signed informed and research consents were obtained. Exclusion criteria were age \< 18 years, Goligher prolapse score IV, pregnancy, previous haemorrhoidal surgery, inflammatory bowel disease. Use of anticoagulant or antiaggregant was not considered an exclusion criteria \[stecca\].

Primary Outcome Measures

Name	Time	Method
the reduction in the blood supply	one month	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.

Secondary Outcome Measures

Name	Time	Method
correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.	one month

Trial Locations

Locations (1)

Ospedale Ca Foncello; 🇮🇹 Treviso, Italy