Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

NCT ID: NCT06175325

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-17
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Hemorrhoids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trans-radial embolisation of haemorrhoids

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

Group Type: OTHER

Trans-radial embolisation of haemorrhoids

Intervention Type: PROCEDURE

Once patients have provided informed consent to participate, an assessment of symptom severity will be obtained during the initial visit using the a standardised set of 4 validated scoring systems used in research of haemorrhoidal disease. These include the French bleeding score (FBS), Goligher classification of internal haemorrhoids (GS), quality of life score (QoL) and Visual analogue score for pain (VAS). Routine blood tests will be taken. During the procedure, routine observations will be recorded on the paper CRF. The data collected on the paper CRF will be entered onto the electronic CRF.

The Transarterial fluoroscopically guided superior rectal artery embolization procedure will be performed on all participants. It is a day case procedure performed under local anaesthetic.

Interventions

Trans-radial embolisation of haemorrhoids

Once patients have provided informed consent to participate, an assessment of symptom severity will be obtained during the initial visit using the a standardised set of 4 validated scoring systems used in research of haemorrhoidal disease. These include the French bleeding score (FBS), Goligher classification of internal haemorrhoids (GS), quality of life score (QoL) and Visual analogue score for pain (VAS). Routine blood tests will be taken. During the procedure, routine observations will be recorded on the paper CRF. The data collected on the paper CRF will be entered onto the electronic CRF.

The Transarterial fluoroscopically guided superior rectal artery embolization procedure will be performed on all participants. It is a day case procedure performed under local anaesthetic.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals of North Midlands NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Aviva Ogbolosingha

Role: primary

aviva.ogbolosingha@uhnm.nhs.uk

01782675380

Other Identifiers

2602

Identifier Type: -

Identifier Source: org_study_id