Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

NCT06175325 | Recruiting

• 1 other identifier: 2602
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Embolisation

Outcome Measures

Primary Outcomes (1)

• Safety and long-term effects

  Safety and efficacy of the haemorrhoid embolisation procedure in relation to the rate of immediate and long-term complications

  3 years

Secondary Outcomes (7)

• Change of symptoms

  3 months

• Change of symptoms

  12 months

• Change of symptoms

  24 months

• Cost comparison

  3 years

• Procedural times comparison

  3 years

Study Arms (1)

Trans-radial embolisation of haemorrhoids

OTHER

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

Procedure: Trans-radial embolisation of haemorrhoids

Interventions

Trans-radial embolisation of haemorrhoids 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.

Trans-radial embolisation of haemorrhoids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 18, 2023
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)