Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

University Hospitals of North Midlands NHS Trust

Status: Enrolling

Conditions: Hemorrhoids

Treatments: Procedure: Trans-radial embolisation of haemorrhoids

Study type: Interventional

Funder types: Other

Identifiers

NCT06175325

2602

Details and patient eligibility

About

Endovascular embolisation is already a common procedure for bleeding haemorrhoids in the acute setting, where surgical options are not possible or have been exhausted. This pilot study aims to add to the small body of evidence that transarterial embolisation of symptomatic haemorrhoids is also safe and effective in the elective setting, providing a good alternative to conventional surgical management. This is a day case procedure that is performed under local anaesthetic. For selected patients, this presents a less invasive management option with reduced potential morbidity. For a health care system under significant financial stress, this provides a potential means of cost improvement, the extent of which this study will try and quantify. A series of 20 selected patients will be recruited to undergo this procedure and then followed up for 24 months. The long-term goal of this pilot study is to form the basis of a national registry of such procedures.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients eligible for the study must comply with all of the following prior to enrolment:

• Patients with grade II-IV haemorrhoid disease with re-current or active bleeding
• Patients with (i) who do not wish to undergo surgery for their symptoms
• Patients with (i) despite recent surgery
• Patients willing and able to give fully informed consent
• Patients aged ≥18 years

Exclusion criteria

• Patients who are not otherwise fit for surgery
• Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses)
• Patient who are unable to sign the informed consent form.
• Patients who are pregnant (completed as part of standard IRMER protocol)
• Patients with history of significant colorectal disease or previous colectomy.
• Patients with history of an allergic reaction to x-ray contrast
• Patients who are currently involved in research

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Trans-radial embolisation of haemorrhoids

Other group

Description:

Haemorrhoids will be treated using arterial embolisation, using a trans-radial approach

Treatment:

Procedure: Trans-radial embolisation of haemorrhoids