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

Not Applicable

• Conditions: Hemorrhoids; Embolization, Therapeutic
• Interventions: Procedure: Transarterial coil embolization

• Registration Number: NCT03805087
• Lead Sponsor: Humanitas Clinical and Research Center

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

Study Timeline

• Study First Submitted: 2018-12-24
• Status Verified: 2019-01
• Study Start: 2019-01
• Study First Submitted QC: 2019-01-11
• Last Update Submitted: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Coil embolization	Transarterial coil embolization	Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.

Primary Outcome Measures

Name	Time	Method
Changes in the severity of symptoms of hemorrhoidal disease	1 years	A 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.

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Lombardia, Italy