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

NCT05627999 | Unknown

• 1 other identifier: OCCaFoncello
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Haemorrhoidal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.

  one month

Study Arms (1)

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

Interventions

doppler endoanal ultrasound PROCEDURE

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.

patients candidate to the haemorrhoidal artery embolization

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale Civile Ca' Foncello: lead

Study Sites (1)

Ospedale Ca Foncello

Treviso, 31100, Italy

RECRUITING

Central Study Contacts

Giulio Aniello Santoro, MD

CONTACT

00393298854361; giulioaniello.santoro@aulss2.veneto.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: January 19, 2023
• Primary Completion: February 19, 2023
• Study Completion: March 20, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (1)