Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids
- Conditions
- Hemorrhoids
- Interventions
- Procedure: Trans-radial embolisation of haemorrhoids
- Registration Number
- NCT06175325
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trans-radial embolisation of haemorrhoids Trans-radial embolisation of haemorrhoids Haemorrhoids will be treated using arterial embolisation, using a trans-radial approach
- Primary Outcome Measures
Name Time Method Safety and long-term effects 3 years Safety and efficacy of the haemorrhoid embolisation procedure in relation to the rate of immediate and long-term complications
- Secondary Outcome Measures
Name Time Method Change of symptoms 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).
Cost comparison 3 years Comparison of the cost (in pounds £) associated with arterial embolisation, using a trans-radial approach to a traditional surgical operation
Procedural times comparison 3 years Comparison with other similar studies using trans-femoral approach regarding procedural times
Radiation dose comparison 3 years Comparison with other similar studies using trans-femoral approach regarding radiation dose
Contrast volume comparison 3 years Comparison with other similar studies using trans-femoral approach regarding contrast volume
Trial Locations
- Locations (1)
University Hospitals of North Midlands NHS Trust
🇬🇧Stoke-on-Trent, United Kingdom