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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
RECRUITINGSafety and long-term effects
Safety and efficacy of the haemorrhoid embolisation procedure in relation to the rate of immediate and long-term complications
Time frame: 3 years
Change of symptoms
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).
Time frame: 3 months
Change of symptoms
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).
Time frame: 12 months
Change of symptoms
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).
Time frame: 24 months
Cost comparison
Comparison of the cost (in pounds £) associated with arterial embolisation, using a trans-radial approach to a traditional surgical operation
Time frame: 3 years
Procedural times comparison
Comparison with other similar studies using trans-femoral approach regarding procedural times
Time frame: 3 years
Radiation dose comparison
Comparison with other similar studies using trans-femoral approach regarding radiation dose
Time frame: 3 years
Contrast volume comparison
Comparison with other similar studies using trans-femoral approach regarding contrast volume
Time frame: 3 years
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