Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

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

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 Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: Trans-radial embolisation of haemorrhoids

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Stoke-on-Trent, United Kingdom
    • University Hospitals of North Midlands NHS Trust
    • Contact: Megan Young; Email: megan.young@uhnm.nhs.uk
    • Principal Investigator: AbdelKader Allouni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Trans-radial embolisation of haemorrhoids; Haemorrhoids will be treated using arterial embolisation, using a trans-radial approach

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Cost comparison	Comparison of the cost (in pounds £) associated with arterial embolisation, using a trans-radial approach to a traditional surgical operation	3 years
Procedural times comparison	Comparison with other similar studies using trans-femoral approach regarding procedural times	3 years
Radiation dose comparison	Comparison with other similar studies using trans-femoral approach regarding radiation dose	3 years
Contrast volume comparison	Comparison with other similar studies using trans-femoral approach regarding contrast volume	3 years

Collaborators and Investigators

• Sponsor: University Hospitals of North Midlands NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Embolisation
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 2602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No