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Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids

Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03805087
Enrollment
50
Registered
2019-01-15
Start date
2019-01-31
Completion date
2021-12-31
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolization, Therapeutic, Hemorrhoids

Keywords

Hemorrhoids, Embolization, Therapeutic

Brief summary

This study will evaluate short , mid and long term efficacy of transarterial coil embolization of the superior rectal arteries (Emborrhoid techinque) for treatment the hemorrhoidal disease.

Detailed description

The 'emborrhoid' technique is the embolization of the hemorrhoidal arteries. The endovascular arterial occlusion is performed using coils placed in the terminal branches of the superior rectal arteries The emborrhoid technique has been modeled after elective transanal Doppler-guided hemorrhoidal artery ligation, which has been shown to be safe and effective for hemorrhoidal disease. To date, there are few reports regarding emborrhoid, particularly lacking in long-term follow-up. Additionally, all procedures reported so far have used a transfemoral access route, which requires at least one day of hospital stay. The aims of this study are: To increase data regarding safety and efficacy of the Emborrhoid technique To report changes in the quality of life of patients at short and long-term To quantify recurrences at one-year follow-up To validate the use of the radial access for the Emborrhoid technique To validate the Emborrhoid technique as a one-day hospital procedure

Interventions

PROCEDURETransarterial coil embolization

Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.

Sponsors

Humanitas Clinical and Research Center
Lead SponsorOTHER

Study design

Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients with at least grade II Hemorrhoids (Banov et al. 1985), agreeing to undergo the Embhorroid technique.

Exclusion criteria

* Absolute contraindications to an angiographic procedure.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the severity of symptoms of hemorrhoidal disease1 yearsA symptom-based severity score (Sordegren scoring system) will be used before and after intervention. It is a questionnaire composed by 4 questions with a final scoring of 0-14 where 14 is the highest possible severity of symptoms. The questionnaire will be administered the day before procedure, one week after procedure and one year after procedure.

Countries

Italy

Contacts

Primary ContactEZIO LANZA, MD
eziolanza@gmail.com0282247383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026