Health TrialsbyHealthPanel

Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

ConditionHemorrhoids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals of North Midlands NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Trans-radial embolisation of haemorrhoids

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Trans-radial embolisation of haemorrhoidsOther 1 intervention

Trial outcomes

Primary outcomes

1

Safety 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals of North Midlands NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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