Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

Official title

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

Overview

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.

Interventions

• Procedure 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 re

Primary outcome measures

• Safety and long-term effects [Time frame: 3 years]

Secondary outcome measures (7)

• Change of symptoms [Time frame: 3 months]
• Change of symptoms [Time frame: 12 months]
• Change of symptoms [Time frame: 24 months]
• Cost comparison [Time frame: 3 years]
• Procedural times comparison [Time frame: 3 years]
• Radiation dose comparison [Time frame: 3 years]
• Contrast volume comparison [Time frame: 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• University Hospitals of North Midlands NHS Trust — Stoke-on-Trent

Identifiers

NCT: NCT06175325 · 2602

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗