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

Sponsor
Ospedale Civile Ca' Foncello (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05627999
Collaborator
(none)
10
1
1
9.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.
Anticipated Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Jan 20, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement. [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Ca Foncello Treviso Italy 31100

Sponsors and Collaborators

  • Ospedale Civile Ca' Foncello

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giulio Aniello Santoro, Surgeon, Ospedale Civile Ca' Foncello
ClinicalTrials.gov Identifier:
NCT05627999
Other Study ID Numbers:
  • OCCaFoncello
First Posted:
Nov 28, 2022
Last Update Posted:
Nov 28, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2022