The following clinical FAQs will help answer your top questions about using the patented CRH O’Regan System, as well as post-procedure care, complications and other related conditions.
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Q: Which patients can be treated using the CRH O’Regan System
A: The vast majority of patients with hemorrhoidal disease are excellent candidates for the procedure. The CRH O’Regan Disposable Hemorrhoid Banding System is suitable for virtually ALL patients with Grades I – III disease, and if you can reduce a patient with Grade IV disease, many of these patients can be treated as well!
Q: Can you REALLY band patients with Grade III disease?
A: Yes you REALLY can! Grade III patients may require more than 3 treatments, and the success rates treating patients with Grade III disease is not quite as high as for Grade II patients, but we have a wonderful track record treating these patients with our technology.
Q: How about patients with only mild to moderate disease?
A: Other techniques are reserved only for the most severely symptomatic patients, as those treatments are associated with significant pain and disability. The CRH O’Regan System, with a complication rate of less than 1%, is perfectly suited to the recurrent mild symptomatic patients, as well as those with moderate to severe problems.
Q: Why can’t I band all 3 columns at once?
A: By banding one column at a setting, the risk of having a complication is 1% (of which pain and bleeding would be most frequent). If more than one column is banded at the same session, the complication rate increases to 6-10%. In the case of multiple bandings, you may also see an issue with urinary retention.
Q:Is the procedure really painless?
A:Yes! After the banding procedure is performed, it is important that the patient feel no pain or pinching sensation. If they do, a simple band adjustment during a rectal examination will alleviate the problem. A feeling of fullness, pressure or tenesmus is normal. The patient will certainly feel the examination, and if they have spasm or a partially healed fissure, that exam will be uncomfortable, but the banding itself, and the post-banding period should be painless.
Q: I’m afraid that I’m not grabbing enough tissue in my band to afford the patient any relief. Is there a minimum size to the “pile” that is banded using your ligator?
A: The techniques that we espouse allow for an excellent clinical response without trapping a tremendous amount of tissue in the band. The band works in two ways: both to help cut off some of the “feeders” to the pile, but most importantly, it causes submucosal scarring, helping to reestablish some of the suspensory connections between the mucosa and the muscularis that are broken down in patients with hemorrhoids. We are not performing a “mini-hemorrhoidectomy”, but rather, more of a “hemorrhoidopexy” with the banding procedure. In fact, the combination of being able to place the bands a bit higher, grabbing only the appropriate amount of tissue, banding a single column at a session, and the atraumatic nature of the procedure using the CRH O’Regan System combine to provide the superior results that have been found using this technique!
That being said, it IS possible to have too little tissue in the band. As a general rule of thumb, you should have a “tuft” of tissue in the band, the size of which depends in large part on how much loose and redundant tissue is present. Our goal is to have enough tissue trapped by the band to assure that the band will remain in place long enough to cause necrosis of the banded tissue. If the banded tissue feels like a pencil eraser or less, you will need to get additional tissue banded to make certain that the band will remain in place long enough to do its job.
Q: What do I do if the patient complains of pain after a band?
A: Typically, the patient complains of a “pinching” pain when too much tissue is trapped within the band, or some excess surrounding mucosa, or tissue which is too close to (or distal to) the dentate line. Trapping of the muscularis is also a possibility. Perform a digital rectal exam, and manipulate the banded pile to make certain that the tuft is “standing straight up”, is not tethered to any other mucosa, and moves freely (so not adherent to the muscularis). If the patient still has a pinching pain, simply roll up the band a mm or two. If that is not sufficient, you can pop the band off with your finger, and then reapply a band a bit more proximally than you placed originally.
It is very important to keep patients in the office for 10-15 minutes after the procedure (especially after their first banding) to monitor them for the development of ANY pain or “pinching”. If either occurs, then manipulation of the band is very important. It sounds a bit silly, but one of the toughest aspects of treating these patients is that you have to make sure that they understand that they are not supposed to have any pain whatsoever. If that patient goes home saying “that isn’t too bad”, then they’ll be calling you back! Pressure or a sensation of needing to have a bowel movement are perfectly normal and typically only last a few hours. Pain or “pinching” are NOT normal and should be addressed.
Q: What about patient complaints after leaving the office?
A: If the above recommendations are followed, then this should be a very uncommon issue. Delayed patient complaints are usually due to muscular spasm, and treatment with topical nitroglycerin* is usually quite helpful. A thrombosed external hemorrhoid will occur in the 1:500-1:600 range and is treated like any other thrombosed external hemorrhoid. If the patient has no contraindications, then a NSAI and/or some topical anesthetic can be used. The best way to avoid any of this is to keep the patient in the office for at least 10 minutes after the procedure, and If the patient looks uncomfortable to you, or has even the slightest amount of pain or “pinching”, then “adjust” the band!
Q: What about sepsis?
A: Pelvic sepsis is extraordinarily rare, and is characterized by fever, chills, pain and urinary retention. One of the presumed etiologies is banding tissue that is too deep, causing necrosis of the muscularis, and a “mini perforation” of sorts. Utilizing the CRH O’Regan System’s atraumatic, gentle suction, followed by a post-banding anorectal examination which assures that the muscularis has not been trapped in the band along with noting a narrow “stalk” to the banded tissue will take full advantage of the safety profile of this procedure.
Q: My patient called after a banding, and stated that they found a rubber band floating in the toilet after their first bowel movement. What should I do?
A: Reassure the patient, and see him/her at their next scheduled appointment. Even though the band usually doesn’t fall off until days 2-5, periodically it will come off earlier, yet still achieve the desired result. As long as the band successfully caused necrosis and sloughing of the banded tissue, it should have done its job.
Q: How do you handle a patient with a post-band bleed?
A: A small amount of bleeding is very common, but significant bleeding is extremely uncommon. Significant bleeding, should it occur, most commonly happens 3-5 days or 10 days – 2 weeks after banding, corresponding to when the banded tissue sloughs and when the resultant eschar separates.
Most patients stop bleeding when lying down, applying ice and drinking fluids. For those that do not, or for those with a substantial bleed, instruct the patient to come to the emergency room. Multiple approaches to treat this type of bleeding are available, from cauterizing the ulcer anoscopically with a silver nitrate stick, using an APC, heater probe, or other cautery device endoscopically for a bleeding ulcer. Should the bleeding be coming from a “pumper”, re-ligation or the application of an endoscopic clip will generally suffice.
Q: How do you deal with patients on anticoagulants?
A: This is a very controversial subject. Patients on anticoagulants may have an increased risk of bleeding in the post-banding period, although one review of 150 patients banded on warfarin, only 1 patient bled, and that was not from the banding site but rather a coexistent fissure, and another showed no significant difference in the bleed rate comparing patients on clopidogrel to those not taking the medication. To date, we’ve not found any reports dealing with the newest generation of anticoagulants.
If the decision is made to hold these medications in and around the banding session, then their Coumadin or Plavix should be stopped on the day of the banding session (if safe and appropriate to do so). Assuming that the patients are on these anticoagulants for a reason, holding these medications can certainly have its own set of problems, so a risk-benefit analysis should be included when planning for these patients’ treatment.
Q: I’ve had terrible problems using nitroglycerin in the past, and I see that you use this quite often.
A: The vast majority of the problems associated with topical nitroglycerin utilized in perianal situations is due to either using too potent a formulation of NTG*, or using too much of it (or both). We have had great success using 0.125% nitroglycerin ointment, and using a “pea-sized” drop on a gloved finger, placed inside the anus 3 times per day. In patients with fissures, the treatment must be continued for 3 months after the fissure is healed, in order to minimize the risk of recurrence.
This strength of topical nitroglycerin* is not available commercially, so it must be compounded. It should be noted that some utilize topical diltiazem* or nifedipine* for the same intended effects, and these medications must be compounded as well.
Q: Who should be treated with NTG* (or if you prefer, topical calcium channel blockers*)?
A: At a minimum, we’ve utilized these compounds with patients presenting with the following:
Dr. Cleator recommends using NTG on the vast majority of patients, as he sees a more rapid healing of the post-banding ulcer, and sees fewer complaints of pain with its use.
* “off-label” use of NTG
Q: What do I do for a patient when NTG is not effective?
A: If 0.125% NTG* administered as recommended is not sufficient, then the frequency or amount of the medication can be increased. If that is not effective, AND if the patient is not having headaches, then you can advance to a 0.2% NTG* formulation. If the patient IS having headaches, then topical Nifedipine* or Diltiazem* can be tried. If all of the above has failed, botulinum toxin* can be administered, 10– 15 units into each side of the internal sphincter. Our protocol was to use 12.5 units per side simply because we were able to obtain a total of 25 units relatively economically! If this fails, then a repeat treatment with 20 units per side may be tried. This strategy results in the healing of 80-85% of the patients with virtually no long-term problems (such as incontinence). If all of the above has failed, then consideration should be given to a surgical procedure (Lateral Internal Sphincterotomy).*
* “off-label” use of drugs
Q: My patient presented with a thrombosed external hemorrhoid that occurred 3 days ago. What should I do?
A: Thrombosed external hemorrhoids can be treated conservatively, but often, if treated acutely with an incision and evacuation within the first 24-48 hours of its onset, relief will be more immediate and more complete. If more than 48-72 hours has passed, then the thrombosis typically begins the “organization” process, and becomes much more difficult to evacuate with a simple incision. In fact, incising these patients’ thrombosis may well lead to a DELAY in their improvement. In most circumstances, topical anesthetics, nitroglycerin* and sitz baths are very helpful. A notable exception to this is for the patient with a several day old thrombosis, and an ulceration with a visible clot. Evacuating the clot can help these patients, and this can be done by topically applying anesthetic cream or ointment and then manually decompressing the thrombosis.
* “off-label” use of drug
Q: Can I band someone that has a coexistent thrombosis or fissure?
A: Definitely maybe! If the patient is very tender because of a thrombosis or fissure, then treatment for the fissure or thrombosis should be instituted, and the ligation of the hemorrhoids should be deferred until their next clinic visit. If the patient is only mildly symptomatic from either of the conditions, then it is perfectly acceptable to begin ligations. These patients benefit tremendously by banding using the “touch technique” (without an anoscope), as the treatment is much less traumatic to the patient.
We think of the DRE as the first “stress test”. If this is tolerated, then the anoscope provides the second “stress test”. If the patient “passes” both of these, then they are typically able to be banded. We tend to defer treating whichever hemorrhoid is closest to the fissure/thrombus until later in the course of treatment.
Q: What if my patients are still symptomatic after 3 bandings?
A: The average number of bandings in our clinics was 3.08, and we found that 10-15% of patients didn’t need all 3 columns banded, and 15-20% needed more than 3 bands. The extra bands tended to not be a “rebanding”, but rather they were deployed between the previous bandings in order to help tack up some of the remaining prolapsing tissue. Grade III patients and patients with leakage issues tend to need those extra bands over and above other patient groups.
We should add here that the most common reason for continued symptoms tends to not be the need for more banding, but rather, that a small fissure was missed! A careful anorectal and anoscopic exam is the best way to evaluate these patients, and be on the lookout for that partially healed fissure! We feel strongly that you do not need to SEE the fissure to know that it is there – the diagnosis of a fissure should be a clinical one, not an “I see it – there it is!” diagnosis!
