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

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

Study Overview

• Status: Recruiting
• Conditions: Haemorrhoidal Bleeding
• Intervention / Treatment: Procedure: doppler endoanal ultrasound

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Giulio Aniello Santoro, MD; Phone Number: 00393298854361; Email: giulioaniello.santoro@aulss2.veneto.it

Study Locations

• Italy
  • Treviso, Italy, 31100
    • Recruiting
    • Ospedale Ca Foncello
    • Contact: Giulio Aniello Santoro, MD; Email: giulioaniello.santoro@aulss2.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients candidate to the haemorrhoidal artery embolization; 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].

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.	one month

Collaborators and Investigators

• Sponsor: Ospedale Civile Ca' Foncello

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): February 19, 2023
• Study Completion (Anticipated): March 20, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Neovascularization, Pathologic
• Other Study ID Numbers: OCCaFoncello

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A prospective observational pilot study was conducted. 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. The secondary aim was to evaluate the efficacy of this treatment by the Hemorrhoidal Bleeding Score and to correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No