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NCT06175325 | NOT YET RECRUITING | Hemorrhoids

Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids
Sponsor:

University Hospitals of North Midlands NHS Trust

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.

Condition or disease

Hemorrhoids

Intervention/treatment

Trans-radial embolisation of haemorrhoids

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Pilot Study of the Safety and Efficacy of Trans-radial Superior Rectal Artery Embolisation for the Treatment of Haemorrhoids
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2026-12-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

Location Details

NCT06175325

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United Kingdom,

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom,