Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175325
• Other study ID #: 2602
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: November 2023
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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 recorded on the paper CRF. The data collected on the paper CRF will be entered onto the electronic CRF. The Transarterial fluroscopically guided superior rectal artery embolization procedure will be performed on all participants. It is a day case procedure performed under local anaesthetic.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and long-term effects	Safety and efficacy of the haemorrhoid embolisation procedure in relation to the rate of immediate and long-term complications	3 years
Secondary	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).	24 months
Secondary	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).	24 months
Secondary	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).	24 months
Secondary	Cost comparison	Comparison of the cost (in pounds £) associated with arterial embolisation, using a trans-radial approach to a traditional surgical operation	3 years
Secondary	Procedural times comparison	Comparison with other similar studies using trans-femoral approach regarding procedural times	3 years
Secondary	Radiation dose comparison	Comparison with other similar studies using trans-femoral approach regarding radiation dose	3 years
Secondary	Contrast volume comparison	Comparison with other similar studies using trans-femoral approach regarding contrast volume	3 years