Rafaelo® webinar transcript

Louise King

Good evening and welcome to our webinar on the Rafaelo® procedure and treatments for haemorrhoids. My name is Louise and I'm your host. You'll see on the screen we have our expert presenters Mr Marzouk and Mr Adamek, experienced Consultants in general surgery and colorectal surgery at Benenden Hospital.

Please note within this presentation there will be photographs of some haemorrhoids, just so you're prepared for that. Also, the presentation will be recorded. After the following presentation there will be a Q&A session where you can ask questions throughout the presentation or at the end through the Q&A icon at the bottom of your screen. This can be done with or without providing your name.

So now I'll hand over to Mr Adamek and you'll hear from me again shortly. Thank you very much.

Mr Jacek Adamek

Thank you kindly for the introduction and welcome to one of our series of webinars. We hope to offer some information to patients about haemorrhoidal disease, the development of the new techniques of treatment and we’ll try to share our experience of various types of treatment. Both myself and Mr Marzouk, my esteemed colleague, have treated several cases of haemorrhoidal disease and we can share our experience to give you a better understanding of the treatment and expectations of our patients.

Let's start the presentation. Haemorrhoid treatment has been running for centuries. It’s been well known since 2500BC when patients were troubled with bleeding, discomfort, itchiness and leakage. The first operation was described in 2500BC and the first time the word ‘haemorrhoid’ was used in English literature was in 1398.

It's a very common condition; a frequent proctological disease which occurs in various forms where typical symptoms are itching, pain, bleeding, with pain and discomfort. Two to three people out of five in the western world are affected by this condition. UK prevalence is 13 to 36%. 50% of those patients are aged 50 years and above.

What are haemorrhoids and why do they happen? So, they're like cushions around the tail end; extra protection seals to protect you from wind escaping and leakage. So, the haemorrhoid grade 1 stage is normal physiology for all of us. They start being symptomatic when they start bleeding or when we put too much pressure against the whole pelvic floor and against the cushions, when we get constipated, when you strain on the toilet, when you do heavy lifting, when the abdominal pressure rises and creates pressure against the pelvic floor muscles. Those are the muscles that support your bladder, your back passage, and they become troublesome.

So, repeated shearing forces with chronic, straining constipation cause disruption of the elastic supporting matrix around the tail end and all of this causes the cushions to become swollen and prolapse from the back passage.

Based on the size and the position of the haemorrhoids, we can divide them into internal, external or mixed and then we grade them from grade 1 to grade 4. It's worth noticing that the grade 1 is normal physiology for all of us. So, we all have the first degree of haemorrhoids; this is not a pathology, this is our physiology.

Second degree - very slightly swollen. The third degree when they’re swollen and prolapsing but can be retracted back and the fourth degree when they prolapse and they present outside the back passage, when they’re strangulated outside. And this is probably the only time that they’re painful, when the mucosa is sitting outside the anal canal.

The mucosa can get ulcerated and pain occurs with it as well. And every single time they bleed - if they’re swollen - they prevent the anal canal being closed properly by the muscle sphincter. And when that happens, the mucosa starts leaking from the back passage and starts irritating the skin around the tail end and other symptoms like itchiness and eczema happen at the same time.

Bleeding is the most common symptom of haemorrhoids. Normally it’s painless bleeding, normally bright red in colour which signifies that bleeding is coming from the distal part of the back passage or left part of the colon. Depending on the concomitant symptoms, we may need to do a flexible sigmoidoscopy to make sure we're not missing anything else in the left colon. The blood is normally not mixed with the stool, this normally happens at the end of the defecation, it happens on the tissue. Occasionally it drips into the pan and, when it mixes with the water, in the pan looks like a significant amount of blood but normally it is only a few drops mixed with the water and looks a lot.

Tissue prolapses after defecation signify the second- and third-degree haemorrhoids. Normally they can be pushed back, or they retract back on their own and do not require any other treatment. Mucus discharge happens with haemorrhoids as well at the same time and, as I have mentioned before, itching of the perianal skin happens as well.

As we discussed before, some haemorrhoids are painful. Normally when they are large or when they prolapse and when they sit outside the back passage. Sometimes they do thrombose, and they are really painful, because they cause tension of the skin around the tail end. This is a highly nervous part of the body and causes a lot of discomfort and pain.

Mild obstructed defecation symptoms which means that you strain on the toilet (because the engorged haemorrhoids are sitting there) may happen as well at the same time.

Normally we ask patients to come to the clinic for an examination and, at the same time, we take the whole family history and whole history of any symptoms and the disease, the duration of the disease, the colour of the blood, what's happening and then we make the decision - should further investigation be required and what treatment can we apply once we make the diagnosis?

We've been through the symptoms already, but they can be swollen, prolapsing and painful when they're outside. When they bleed more and more something needs to be done about it. When we examine the patient, we need to extract any other pathology around the tail end; we're talking about cancer, thrombosis, any other inflammatory bowel disease and any other disease of the back passage such as rectal prolapse or pelvic flow dysfunction.

Treatment can be approached in stages. Normally haemorrhoids do not require surgical intervention. Changing your lifestyle and modification of your diet will bring an improvement to your symptoms. Occasionally we may need to put you on medical therapy then we can move towards the office-based procedures such as haemorrhoid banding, the Rafaelo® procedure (which is becoming more common now in outpatient settings with local anaesthetic, without any sedation) or more advanced haemorrhoids which require proper surgery with the use of the theatres and general anaesthetic.

Lifestyle modification and medical treatment of haemorrhoids. We're talking about avoiding constipation, avoiding any strenuous activities, adequate hydration to make the motion softer and moister and use of bran in your diet to help everything stay in the lumen (the opening inside the bowels) and for the motion to travel smoothly through the large bowel.

Occasionally your GP may prescribe a local application of Proctosedyl or Anusol, just to help ease the symptoms.

There are various surgical procedures which we can apply for the treatment of haemorrhoids. We're not going to discuss all of them today, but the most commonly used one we’ll discuss as an outpatient surgical procedure will be Rubber Band Ligation and the Rafaelo® procedure, which is the main aim of our presentation today.

The aim of this treatment is to reduce the amount of redundant tissue in the anal canal, reduce the vascularity, cut off the blood supply to the cushions of the haemorrhoids and try to hitch the haemorrhoids, which will go up the anal canal and stop prolapsing. And then, if the blood supply is cut off, the haemorrhoids will shrivel up. Any external components of the haemorrhoids which are sitting below the dentate line will require a general anaesthesia, as these procedures are very painful.

Rubber band ligation - known for decades, if not centuries - a very common procedure when we apply an endoscope into the back passage. We visualise the haemorrhoid and we apply a rubber band to the blood supply, as seen on the picture. The rubber band stays there for few days to a week and normally they drop off after a while. You may notice a bit of bleeding by which time the haemorrhoid should be thrombosed and, after a few weeks, should start shrivelling up and decrease in size.

A new treatment for internal haemorrhoids called Rafaelo®. The technology been used for long time now, it's been used for laser vein therapy for varicose veins and now it’s been modified to use for haemorrhoids as well.

The most common are first and second degree for Rafaelo® haemorrhoids, which can be performed in the outpatient setting. Third-degree haemorrhoids also could be addressed but I think they are a bit more pronounced and require (in the majority of cases) a general anaesthetic. The experiences with third-degree haemorrhoids will be shared with us by my colleague Mr Marzouk, who has performed several operations for the third degree. I've done the majority of patients for the first- and second-degree haemorrhoids under local anaesthetic, a bit of sedation in outpatient settings and a few, very few for the third-degree under anaesthesia.

So, what is the Rafaelo® procedure? It’s a radio frequency ablation of the haemorrhoids under local anaesthetic. The probe produces a radio frequency thermal injury to the cushion of the haemorrhoids to cut off the blood supply to the haemorrhoid. It's an outpatient setting procedure and doesn't take very long. We inject a bit of local anaesthetic once the patient is in the room, then we apply the probe into the haemorrhoid cushion, apply the thermal application of the radio frequency via a probe and - when we see the haemorrhoids shrivelling down and changing colour - then we withdraw the probe and cool down the area with cold saline. Normally, the patient just gets up from the couch and walks out of the room with minimal discomfort and we provide painkillers to take home.

That's for first and second degree haemorrhoids; that's the anoscope and the radiofrequency probe which goes into the cushion of the haemorrhoids which you can see on the left-hand side of the screen. And then on the right-hand side, you can see slightly whitish tissue after the ablation of the haemorrhoid once the probe has been removed. And then we wait for the final stage of the treatment which takes place in the next few days.

This is the device which produces the radio frequency and the probe next to it, and this is a the step-by-step Rafaelo® procedure explained as I just said: anoscope into the back passage then the local anaesthetic. Picture number two shows that the local anaesthetic is injected underneath the haemorrhoidal cushion and above the muscle layers of the rectum just to avoid any additional pain and injury to the muscle. Then the probe is inserted into the cushion itself, lifted off the anal wall and the frequency ablation is applied. It doesn't take long; the temperature of the frequency ablation is 100-120 degrees Celsius; it lasts for a few seconds and then we apply cold saline to cool down that area.

The ablation is applied in several places of the cushion, depending on the size of the cushion, but we start from the top of the haemorrhoids and then we work our way down towards the lowest part of the haemorrhoid. All of this has to be applied above the dentate line of the anal canal.

That treatment does not affect the skin component. It can be applied in two sites or three at the most at any one time. There are excellent results from the long-term follow-up; recurrence rate is calculated between 12 to 18 percent and the recurrence normally is on the other site than the treated site of the haemorrhoids. As you can imagine, the haemorrhoids are in 12 places in your anal canal so if we treat two or three of them you may develop haemorrhoids on another site of the anal canal if you don't change your lifestyle, if you still get constipation or do heavy lifting as strenuous activities.

Other surgical treatments which are quite extensive and require a general anaesthetic are open resection of the haemorrhoids called Milligan-Morgan. They are quite uncomfortable or painful for the patient for two weeks after the surgery and I tend not to see my patient, to be honest, for four weeks because they don't really like me for that time! But after four weeks they start smiling and start appreciating the outcome of it. But in the first two to three weeks they are really not happy, and I share that pain with them, because it's quite drastic procedure.

We can also do an EnSeal haemorrhoidectomy. Mr Marzouk is an expert in that field. We used to do the stapling haemorrhoidopexy called PPH but personally I abandoned that a few years ago, due to the long-term outcomes of the PPH. The other procedures are the HALO procedure, THD and laser procedures but all of them would require a general anaesthetic.

So, for more advanced, more troublesome, haemorrhoids with mucosal prolapse we've got various modalities of treatment - but those treatments would require general anaesthetic while the Rafaelo® procedure can be walk in and out from the outpatient setting.

This is the EnSeal, so I will ask Mr Marzouk to comment on this procedure please.

Mr Deya Marzouk

Yes, the EnSeal is – essentially - a better way of cutting and sealing. So traditionally haemorrhoidectomy, when you require more treatment - either because the simpler treatment has failed, or the patient has larger haemorrhoids and especially if they have a large skin component - they need some form of haemorrhoidectomy. And traditionally this is started using just the scissors, then electric currents use diathermy to cut and stop the bleeding.

But the advantage of using this EnSeal is that you could sort of almost tailor it to that. You pull it and then apply the jaws to it. It will first sort of burn it and cut it, but it has an advantage because the so-called ‘thermal injury’ or the injury from the heat generation or the coagulation of this machine is actually quite limited. So, compared to other ways of coagulating haemorrhoids it actually just seals the edges and brings them together without damaging any surrounding tissues.

So we like it, but it still has the major disadvantage - like any of the other excisional haemorrhoidectomies - of causing significant post-operative pain and Jacek has been very clear throughout this presentation, trying to say that we have tried to move away from excisional forms of haemorrhoidectomy into other, simpler treatments because the excisional haemorrhoidectomy tends to be quite painful. But it's also very effective and exactly like Jacek said, I also try to avoid it for patients. I tell them in the clinic that you will hate me for three to four weeks and then you'll love me afterwards. Very similar story. Back to Jacek,

Mr Jacek Adamek

Thank you. So, one has to realise that one size doesn't fit all. So that means that Rafaelo® won't be suitable for every single patient who will come with haemorrhoidal symptoms. Each procedure needs to be tailored to the stage of the haemorrhoids and the symptoms of the haemorrhoids.

We will answer all those questions later on who is suitable, who is not suitable. Let's run through the post-operative complications (if any) after haemorrhoidal treatment.

Pain or discomfort after the Rafaelo® procedure is one of those. A small amount of bleeding may be experienced for the patient, occasionally they can notice a bit of ulceration at the site of the treatment of the haemorrhoids. What's most important postoperatively is to have regular painkillers to be taken for the next three to four days on a regular basis and then as required; avoid constipation; regular motions and keep the site clean - otherwise there are no further major complications noted whatsoever.

As I said, one size doesn't fit all, so then when we see the patient we assess the haemorrhoids then we make the decision as to what would be the best, suitable, most successful procedure for the stage of the haemorrhoids you present in the clinic. And as a hemorrhoidal treatment for internal haemorrhoids, Rafaelo® will be absolutely fine. But for those who are prolapsing to the third or fourth degree, they are more advanced. So, third degree sometimes can be treated with Rafaelo®, but would require a general anaesthetic. Fourth degree is not suitable as they are sitting outside the anal canal and we cannot apply all this radiofrequency ablation with the heat into that area - because it's extremely painful and wouldn't be tolerated by the patient. And the outcomes are not that great anyway, hence we’ve got the other modalities of treatment - including EnSeal or the open haemorrhoidectomy as the last stage of the treatment.

We can open the session for questions from the audience, please. We're happy to answer should you have any.

Louise King

Thank you. I will go through the questions now if that's okay. That's a really interesting presentation, so thank you. Our first question is: am I allowed to drive myself home after the Rafaelo® procedure?

Mr Jacek Adamek

Yes, so if you have it under local anaesthetic with no sedation, by all means yes - if you feel comfortable. If sedation is given then absolutely not - you have to be driven home and somebody must stay with you at home, exactly the same as if you're coming for a colonoscopy with sedation.

Louise King

Excellent, thank you. And the next question is what is the difference in recovery time for Rafaelo® versus, say, a haemorrhoidectomy? Mr Marzouk, would you like to answer this?

Mr Deya Marzouk

It's a big difference. Rafaelo®, if you do it in first and second degree haemorrhoids, the patient will actually - if you see them early, in my early patients I decided to see them after a week - and some of them reported no pain at all, some reported some discomfort for a day.

So, the recovery tends to be in matters of days even for those who have had Rafaelo® under a general anaesthetic for very large haemorrhoids. It was their choice; they still reported some degree - maybe maximum a couple of days - and still recovered after that. It is consistent with all conventional haemorrhoidectomies, that patients will have a significant degree of pain and obviously patients are different in their threshold and pain tolerance, so some patients would just tell you that they had pain for about a week if you have, say, treated one site. But if you've treated two sites or three sites a lot of them would really report a significant degree of pain for about three weeks.

And I think the issue here is that, if you tell the patient honestly about this, they are more prepared. Because if they don't know this, they think that something wrong happened with the operation and so, it is vital that they know the difference. And this is not to try to sell the haemorrhoids and undersell the traditional haemorrhoidectomy, because they are really very complementary - they cover different types of haemorrhoids and they are not really direct competitors. But it is very important that, when you see a patient you try to be as honest as possible and define what you're trying to achieve from this treatment - and give them a realistic outlook to what they should expect.

Louise King

Thank you. Mr Adamek - is there a long waiting list on the NHS for procedures like this as I'm weighing up paying or waiting and the benefits for each. Could you cover that off?

Mr Jacek Adamek

Well due to COVID, there's a massive backlog in the NHS and, of course, the procedures in the NHS are prioritised depending on the urgency and the severity of the cases. So of course, the cancer cases take the priority. I'm not saying haemorrhoidal disease is not important, but it's not lethal, therefore they are going to be postponed to the later stage until we clear out all the backlog with these serious conditions to be treated. So, all in all I think the answer is yes, the waiting list is quite significant.

Louise King

Thank you. Okay, Mr Marzouk. How do I know if I need Rafaelo® treatment for my haemorrhoids?

Mr Deya Marzouk

I think the most important thing is that the patient needs to know what his real and dominant symptom is. So, if the patient comes because they are having difficulty in cleaning or because they have itching or anything to do with the skin, they are not suitable for Rafaelo®. Rafaelo® is designed purely to control bleeding, although even in an advanced state the haemorrhoids will actually shrink a bit inside - but it will still leave a lot of external haemorrhoids.

So, if the patient’s main symptom is a lot of bleeding, then Rafaelo® may be suitable, even those who have a one-site prolapse. Sometimes, to a certain degree, prolapse will occur only at one single site; they may still benefit to a degree from the Rafaelo®, provided they actually have a realistic expectation, they understand it is mainly designed to shrink it a bit, to stop the bleeding but not to remove any significant prolapse or any external component.

Louise King

Okay thank you. Mr Adamek, this person says I've had haemorrhoid treatment before and they have returned. Does this treatment have better outcomes or results?

Mr Jacek Adamek

So Rafaelo® is, again, not one size fits all. Depending on the size of your haemorrhoids and the placement of the haemorrhoids, we can offer Rafaelo® treatment. As I said, the success rate is about 82 per cent as compared to the ligation of haemorrhoids, where the failure rate is about 60 percent. So, this is a very good, efficient procedure. But it has to be assessed on a case-by-case basis, depending on the symptoms and presentation at the time.

Louise King

Okay thank you. Mr Marzouk - are there any side effects to having this treatment?

Mr Deya Marzouk

Can you say that again?

Louise King

Are there any side effects to having this treatment?

Mr Deya Marzouk

No, if it is done properly, making sure that when we inject a bit of anaesthetic to separate it from the muscles because essentially the Rafaelo® sort of cooks the inside of the haemorrhoids - and sometimes the surface as well - so as long as it is separated from the muscles, it doesn't damage the muscle in any way. The degree of discomfort, as I mentioned, is minimal and occasionally a patient may bleed again one or two days later but this is the same with any hemorrhoidal treatment. One has to take an adequate history, make sure that the patient is not on anticoagulants or something like that which may become problematic.

If the patient restarts the anticoagulants because - whether you do an open haemorrhoidectomy or Rafaelo® - there is a chance that part of the haemorrhoid will sort of form like a scab and then fall off. And if the patient is on an anticoagulant they will bleed. So, in general, very minimal discomfort - occasionally a spot or two blood but very rarely. If the patient is on anticoagulant, then they may actually bleed a little bit more but that should be anticipated and we can we can manage that.

Louise King

Lovely thank you. Mr Adamek, how long does the procedure take?

Mr Jacek Adamek

It all depends how many haemorrhoids we're going to treat but, all in all, about 15 minutes from entering the room to leaving the room.

Louise King

Great thank you. Mr Marzouk, how would I prepare beforehand for the Rafaelo® procedure?

Mr Deya Marzouk

You make sure that you understand the aims of the treatment and make sure that your expectation is correct in terms that you should not expect that the Rafaelo® will cause you to have a shrinkage of skin tags for example. In general, the patient - if they are coming to be done under local anaesthesia - they don't need any special preparation. Even when they come to have it under general anaesthetic because you have very large and multiple sites and it is preferable to do it on a short general anaesthetic. We now prefer not to give the patient any preparation because if the patient gets an enema it just becomes messy during the surgery. It's actually easier to do it without preparation at all, so patients just need to come and have the operation and it should be all right actually.

Louise King

Okay thank you. Mr Adamek, what kind of lifestyle changes can I make to avoid haemorrhoids?

Mr Jacek Adamek

So, as I said, have a regular motion on the softer side, avoid constipation, have plenty of fluid to moisten your motions, you should avoid any strenuous activities which put a lot of pressure in your abdomen and then transfers it down to the pelvic floor, that's very important. Losing weight is a very important life change to avoid haemorrhoids. Loads of haemorrhoids happen during pregnancy; it is due to the pressure of the pregnancy development itself and pressure against the pelvic floor. So simple measures make a big difference.

Louise King

Okay thank you. Only a couple more questions to go! Mr Marzouk, we have a question. Can I choose what anaesthetic I would like, for example local, mild sedative or general?

Mr Deya Marzouk

Yes. By and large we are happy to offer Rafaelo® for first- and second-degree haemorrhoids, one or two sites. Because a lot of the early patients that have come to Benenden actually came with haemorrhoids outside the classical indications for Rafaelo® and if they have really - I've treated some with circumferential haemorrhoids with Rafaelo® - and these patients actually, ideally, they should be treated under general anaesthetic for the simple reason that the amount of energy used to cook the haemorrhoids at multiple sites becomes too much and sometimes we give them more local anaesthesia. So it's a bit more of an involved procedure. It still takes about 15 to 20 minutes; it's not long but it is a bit more involved. So, by and large, yes, the patient can choose - unless we say ‘this may be too much for you’.

If we're talking about an excisional haemorrhoidectomy, if somebody comes with a skin tag or an external component, they still can have it done with either a spinal or epidural or a general anaesthetic. Local is possible but only possible for really small skin tags. It’s all to do with how much the patient can tolerate the injections because even the local, if you do it in the skin, it can start to sting first before it numbs the area. The injection, that local anaesthetic that we use in first and second degree Rafaelo®, is given essentially in a numb area of the body. But if you inject in the skin around the back passage that's much more painful than that injection.

So, by and large, if it is an excision haemorrhoidectomy some form of a general or spinal anaesthesia is acceptable. Even something called caudal block, which is a special form of local treatment that has to be given by an anaesthetist. But if we're talking about Rafaelo®, a large majority of them can be done with simple anaesthesia. But if - on the other hand - a patient is very anxious and wants to be asleep we can accommodate that as well.

Louise King

Thank you, a very good comprehensive answer. Our last question, which I will pose to you Mr Adamek is: will I need to return to the hospital after the procedure for a follow-up consultation?

Mr Jacek Adamek

So, we’ve got a regular follow-up for the patients and we try to see them within a week and then after six weeks and see what the outcome of the treatment is. By following that protocol, we can collect the data, treating the same way and following up the same way so when we present our data it's comprehensive data and it's comparable.

Louise King

Okay and we just have one more comment: thank you for a really helpful presentation.I can tell you who, but they were very appreciative!

Mr Jacek Adamek

Sorry we didn't hear that one - you were breaking up!

Louise King

It was a just a thank you from an anonymous person for the presentation. They said it's very helpful.

So, thank you so much both of you for the presentation for your time and your knowledge, it's really interesting. If anyone else does have any more questions that they didn't have the chance to post, or they felt embarrassed, please do email them to the email address on your screen and we will get through them. At the end of this presentation you will receive a short survey and we'd be really grateful if you could just give us your feedback.

Our next online event is on Wednesday the 6th of October, so next Wednesday, at 7pm. It's with Consultant Gynaecologist, Mr Gupta and Clinical Nurse Specialist Jan Chaseley on continence care. So, on behalf of Mr Marzouk and Mr Adamek, myself and the team at Benenden Hospital, I would like to say thank you so much for joining us today and we look forward to seeing you again soon for another webinar so thank you very much.

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