Advice
The technology
The technology
eXroid (eXroid Technology Ltd) is a minimally invasive treatment that applies direct current electrotherapy to the blood vessels of a haemorrhoid. This is to interrupt blood flow and shrink the haemorrhoid. The mucosa is not penetrated during treatment. The system includes a generator and connection leads (to deliver current), reusable patient pad, and sterile single-use probe pack (including a sponge pocket, probe and an anoscope to evaluate the anal canal).
During treatment with eXroid, the patient lies on a single-use, saline-soaked sponge that slides into the reusable patient pad. A single-use, negatively charged, disposable dual-probe tip is attached to a control handle. The dual-probe tip delivers electric current (but not direct heat) to the base of the haemorrhoid. The current applied to the haemorrhoid is increased to a maximum of 16 milliamps by pressing a control button on the handle.
Duration of treatment depends on the grade of the haemorrhoid being treated and the patient's tolerance. In practice, the average treatment time is approximately 10 minutes per haemorrhoid. The manufacturer recommends treatment times of approximately 4.5 to 20 minutes. Topical anaesthetic can be offered to patients with anal fissures, who may find the procedure more painful.
Innovations
Unlike other therapies, the technology uses direct current electrotherapy and does not require any general, regional or local anaesthesia.
Current care pathway
A NICE clinical knowledge summary on managing haemorrhoids recommends urgent referral in people with: suspected malignancy, extremely painful, acutely thrombosed external haemorrhoids who present within 72 hours of onset for assessment, reduction or excision, prolapsed and swollen, or incarcerated and thrombosed internal haemorrhoids, or perianal sepsis. For all other haemorrhoids, conservative treatments are recommended including advice on lifestyle changes to minimise constipation and straining, laxatives, and pain-relief medication or topical haemorrhoidal preparations to provide short-term symptomatic relief.
For people with first-, second- or third-degree haemorrhoids that do not respond to conservative treatment, surgical or non-surgical treatments in secondary care are offered (for more information, see the NICE interventional procedures guidance on electrotherapy for the treatment of haemorrhoids). For people with fourth-degree haemorrhoids that do not respond to conservative treatment, surgery is likely to be the only appropriate treatment.
The NICE interventional procedures guidance recommends that current evidence for treating grade 1 to 3 haemorrhoids is adequate to support electrotherapy, provided that normal arrangements are in place for clinical governance, consent and audit. The guidance also recommends that patients should be informed about other treatment options, including non-surgical treatments for lower-grade haemorrhoids, in which electrotherapy is not always successful, and repeat procedures may be necessary. They should also be told that the procedure can be painful, and general or regional anaesthesia might be needed to give electrotherapy at higher currents.
Population, setting and intended user
eXroid is for people who have first-, second- or third-degree internal haemorrhoids. This is as an alternative to other non-surgical treatments such as rubber band ligation, injection sclerotherapy or bipolar diathermy, as well as surgical treatments such as haemorrhoidectomy or stapled haemorrhoidectomy. eXroid should not be used in people who have a pacemaker or defibrillator implant (unless a cardiologist has confirmed the procedure is safe), a bleeding disorder, an active anorectal infection, those who have active inflammatory bowel disease or a lower abdominal transplant, those who are having anticoagulant therapy, people who are pregnant or have purely external haemorrhoids.
eXroid is for use in outpatient clinics or primary care centres, by a clinician fully trained and certified to give eXroid treatments.
Costs
Technology costs
The company does not sell eXroid to clinics but instead agrees treatment fees with clinicians and room-use fees with individual clinics in the UK. For NHS clinics, fees are negotiated depending on how many patients would receive treatment. No NHS trusts currently do eXroid treatments, but 2 NHS patients have had treatment under exceptional circumstances. The current price charged to self-paying individuals is £1,250 for the first consultation, examination and first eXroid treatment. Additional treatments cost £745 each. The company states that prices can be negotiated for multiple treatments. Currently the treatment is only available in London.
The company reports that 50% of patients need 1 treatment. Of patients who need more than a 1 treatment, 80% have 2 treatments and 20% have 3 or more treatments. The average cost per treatment is £998 (if 2 treatments are needed) or £913 (if 3 treatments are needed). The company states that this cost should be an estimate for how much the treatment will cost on the NHS.
Costs of standard care
Conservative comparator treatments includes laxatives, symptomatic pain-relief medication and topical treatment for haemorrhoids. The NHS indicative price for a standard bulk-forming laxative such as ispaghula husk is priced at around £2.50 for 30×3.5 g sachets. A 32‑pack of 500 mg paracetamol caplets is £0.20. These would be supplied as repeat prescriptions and cost would vary depending on how often a person presents with symptoms and the duration of their treatment. The price of a topical haemorrhoid treatment, for example based on the local anaesthetic cinchocaine, is between £4 and £10 for a 30 g tube of ointment. These prices are taken from the BNF.
Non-surgical and surgical comparators are available in secondary care. Table 1 lists spell costs (the cost of a person's entire hospital stay, which could include multiple episodes), taken from the 2010 costs for NHS Hertfordshire and unit costs from published UK economic evaluations for some of these options. In general, the reported upper bound of the spell cost ranges will be higher than reported unit costs because they are meant to capture all costs from admission to discharge. Also, the spell cost range is wide because of the varied type of patients recorded. All of these costs have been appropriately adjusted for inflation.
Non-surgical treatments are recommended for first-, second- and small third-degree haemorrhoids if conservative treatments are ineffective. These treatments are rubber band ligation, injection sclerotherapy, infrared coagulation or photocoagulation and bipolar diathermy (table 1). UK unit costs for infrared coagulation and bipolar diathermy could not be found in published literature.
Surgical treatments are recommended for patients with fourth-degree haemorrhoids. Spell costs and unit costs for haemorrhoidectomy and stapled haemorrhoidectomy are in table 1. Unit costs for haemorrhoidal artery ligation could not be found in the published literature but an Italian study (Giamundo et al. 2011) reported the one‑off equipment cost as €350 (£295 after inflation adjustment and currency conversion).
Table 1 UK unit costs for surgical and non-surgical comparators
|
Non-surgical and surgical comparators |
spell costs |
unit costs |
unit costs |
unit costs |
|
Rubber band ligation |
£605 to £2,681 |
– |
– |
£112 |
|
Injection sclerotherapy |
£605 to £1,076 |
– |
– |
– |
|
Haemorrhoidectomy |
£658 to £2,585 |
£819 |
£1,098 |
– |
|
Stapled haemorrhoidectomy |
£820 to £1,198 |
£984 |
£1,070 |
£1,811 |
Resource consequences
According to the company, the device is not currently used on a regular basis by any NHS trusts. Therefore, it is difficult to predict what the consequences of resource use will be. Treatment with eXroid does not need special preparation or hospital stay, so no additional facilities or devices are needed with the technology. Training will be needed for healthcare professionals using the technology. No other practical difficulties have been identified in using or adopting the technology.