Haemorrhoidal BleedingNCT05627999
Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.
An observational study of Haemorrhoidal Bleeding, run by Ospedale Civile Ca' Foncello at 1 site in Italy.
Trial summary
To evaluate the usefulness of endoanal ultrasound in the evaluation of emorrhoidal artery embolization outcomes Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Haemorrhoidal Bleeding
- What is being tested?
- doppler endoanal ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jan 2023to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- age < 18 years, Goligher prolapse score IV, pregnancy, previous haemorrhoidal surgery, inflammatory bowel disease.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Ca Foncello
Treviso, 31100
Giulio Aniello Santoro, MD, giulioaniello.santoro@aulss2.veneto.it
About this study
To evaluate the usefulness of endoanal ultrasound in the evaluation of emorrhoidal artery embolization outcomes
Read the 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.
- Conditions
- Haemorrhoidal Bleeding
- Being tested
- doppler endoanal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler endoanal ultrasoundProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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]. Receives: Procedure: doppler endoanal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (1)
correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start19 Jan 2023
- Primary completion19 Feb 2023
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemorrhoidal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Civile Ca' Foncello
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Aniello Santoro, Ospedale Civile Ca' Foncello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627999
- Sponsor's protocol ID
- OCCaFoncello
- Status last verified
- Feb 2023
- First submitted
- 16 Nov 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-anal Eco-doppler Evaluation of Haemorrhoidal Vascularization After Percutaneous Hemorrhoidal Artery Embolization. A Pilot Study.
- ClinicalTrials.gov ID
- NCT05627999
- Acronym / sponsor ID
- OCCaFoncello
- Conditions
- Haemorrhoidal Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ospedale Civile Ca' FoncelloUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 19 Feb 2023 (actual)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients candidate to the haemorrhoidal artery embolization | – | Procedure: doppler endoanal ultrasoundConsecutive 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]. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- age < 18 years, Goligher prolapse score IV, pregnancy, previous haemorrhoidal surgery, inflammatory bowel disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doppler endoanal ultrasoundThe 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. | Procedure or surgery | patients candidate to the haemorrhoidal artery embolization |
Primary outcome
the reduction in the blood supply
Time frame: 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.
1 secondary outcome
correlate the systolic peak reduction at the doppler analysis with the patients' symptoms improvement.
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemorrhoidal Bleeding, run by Ospedale Civile Ca' Foncello at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulio Aniello Santoro, MD (00393298854361, giulioaniello.santoro@aulss2.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the reduction in the blood supply (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.