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NCT Number: NCT06175325

Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

Location status: Recruiting

Location contact

AbdelKader Allouni

PRINCIPAL_INVESTIGATOR

Aviva Ogbolosingha

CONTACT

[email protected]

01782675380

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Safety and long-term effects

    Time frame: 3 years

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

Secondary outcomes

  1. Change of symptoms

    Time frame: 3 months

    Improvement in haemorrhoid related symptoms at 3 months using a questionnaire consisting of 4 standardised scoring systems. 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).

  2. Change of symptoms

    Time frame: 12 months

    Improvement in haemorrhoid related symptoms at 12 months using a questionnaire consisting of 4 standardised scoring systems. 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).

  3. Change of symptoms

    Time frame: 24 months

    Improvement in haemorrhoid related symptoms at 24 months using a questionnaire consisting of 4 standardised scoring systems. 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).

  4. Cost comparison

    Time frame: 3 years

    Comparison of the cost (in pounds £) associated with arterial embolisation, using a trans-radial approach to a traditional surgical operation

  5. Procedural times comparison

    Time frame: 3 years

    Comparison with other similar studies using trans-femoral approach regarding procedural times

  6. Radiation dose comparison

    Time frame: 3 years

    Comparison with other similar studies using trans-femoral approach regarding radiation dose

  7. Contrast volume comparison

    Time frame: 3 years

    Comparison with other similar studies using trans-femoral approach regarding contrast volume

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study title

Pilot Study of the Safety and Efficacy of Trans-radial Superior Rectal Artery Embolisation for the Treatment of Haemorrhoids

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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