Oil and Water (Sometimes): Guidelines and Real Life
I had another case the other day when I had no choice but to throw well-documented guidelines for the care of diabetes right out the window.
The patient was a man in his forties with a terrible case of diabetes. The main reason it was so terrible was that he was either completely incapable of or unwilling to comply with lifestyle changes such as limiting carbohydrates in his diet and engaging in regular exercise. His hemoglobin A1c was 13% (good diabetes control being considered less than 7%.) He'd come in at irregular intervals through the years and swear he would do better, but never did for more than a few months at a time.
He recently had a colonoscopy for some rectal bleeding, and was found to have a 4 cm. sessile polyp that was too big to remove through the scope, but did contain cancer in the biopsy specimens. The required procedure is an operation to remove the section of colon containing the cancer.
I only found out about this three days prior to the proposed procedure, when the surgeon's office faxed me a form requesting "medical clearance."
What to do?
All surgery carries risk. The risks in diabetics are magnified; both short term risks like infection and the longer term risk of impaired healing. Surgery for immediately life-threatening conditions (ie, appendicitis) trumps these risks, and the patient must be taken to the OR regardless. But the biology of cancer is such that in this particular case, a delay of three to six months -- or even a year -- is not going to realistically affect the clinical course of the patient's malignancy.
This can be counterintuitive to the general public. How is it possible that cancer is not a surgical emergency? Aren't women with breast masses rushed into surgery? Well, yes, but frankly because it is more of a psychologic emergency than a true medical one. The stress of knowing one has cancer is significant, and it would indeed be cruel to prolong the wait for definitive treatment. But when there are other conditions that significantly increase the risk of surgical complications, that risk/benefit ratio becomes a lot trickier to calculate.
In this case, though, the answer was clear. The surgery needed to be delayed at least 3-6 months so that he could get his diabetes under better control. I called the surgeon, who acknowledged that the cancer posed no immediate threat to his health and agreed to cancel the procedure for now. He told me to call him when the patient was ready to be re-scheduled.*
I hadn't seen the guy for two years, so I made him come into the office, mainly so I could explain to him face-to-face why I thought the surgical risk was unacceptably high while his diabetes was so dreadfully out of control. Here were some other things he said to me to try and persuade me to allow him to proceed with the surgery now:
- He had already arranged to take time off from his job for the operation (which had been scheduled for the next day) and
- If he didn't have the surgery now and lost his job in the next few months -- as he was afraid might happen, as his company was planning layoffs -- he wouldn't have health insurance to pay for it.
Here was the biggest problem: the patient absolutely positively could not swallow pills. Any size; any shape; couldn't swallow them. He had tried. He had swallowed one metformin tablet and it had "gotten stuck." He suffered with the sensation of a foreign body at the base of his neck -- the pill -- for days. There was no way he could do it. Even to save his life -- which he recognized was the case; if he didn't have the surgery at some point, the cancer would eventually kill him -- he just could not do it.
On the other hand, he had no problem with insulin. He had given it to his father for years before the father died (of diabetes complications, of course) so he was at ease with measuring and administering it, even to himself. (He later confessed that he had been on it for a short time many years ago with a previous doctor.)
So along with the most explicit, emphatic discussion of diet and exercise ever provided, I gave him a prescription for insulin: long-acting at bedtime, regular for meal coverage, syringes, new strips and lancets for his meter; the works, but with no oral medications.
There's no guideline in the world that recognizes this as a valid approach for the treatment of type 2 diabetes. But I don't have the luxury of treating guidelines; I treat patients, limitations and all.
*(For all you purists out there, what if the patient doesn't come through with improved control in the given time frame? As time goes on, the urgency of removing the cancer will grow and will eventually outpace even the risks from uncontrolled diabetes. Then he'll get his surgery -- as well as a postoperative infection and non-healing wound -- but at least we'll have done everything possible to avoid it in the first place.)
21 Comments:
To be fair to the patient, those Metformin pills are huge! My dad and I joke that they're horse pills (I was diagnosed with type II 8 years ago and after losing 50 lbs, no longer require medication. Yay for me!) I'm not saying that the patient is right mind you... but it's his choice what with that whole informed consent dilemma. He's of sound mind and can therefore decide what is right for himself. Kudos for being flexible to the patients needs doc!
That must have been such a frustrating situation. Are there ways of dissolving pills into liquid or grinding them down to mix with food or something? His inability to take pills can't be the only reason why his diabetes is out of control. Does he realize that his lifestyle and having diabetes may have been contributing factors to his polyp?!
Stupid question . . . I usually limit myself to baking suggestions...but, could you walk me through the decisionmaking process between insulin therapy and Byetta? My understanding of insulin in Type II is that it always leads to weight gain and lipids changes. I'm not questioning; I'm just trying to understand for myself.
E
At my job (RN serving inpatient stroke victims) my patients routinely can't swallow pills. I crush them and put the powder in a bite of applesauce/pudding/etc. It tastes bad, but they always chase it with something yummy. Alternately, I also cut pills into small bits and "hide" them in the middle of a bite of pudding, which is swallowed in a big gulp. One patient wanted his crushed pills dissolved in a shot of juice, which worked. Another ate the powder straight, which almost made me barf, but he liked better than eating it with pudding. In serious cases, we drop NG tubes to give the meds.
The point is that there are many ways to get oral meds into people who can't swallow pills. An insulin-only program isn't necessary.
Putting a guy like this with such a high Hgb A1c on insulin might actually be the best thing to do. Because of long term "glucose toxicity" you might be able to restore considerable pancreatic islet cell function by putting him on aggressive insulin management so that eventually he may do well on long acting insulin alone or that combined with one of the newer agents like Byetta. An older endocrinologist introduced me to the concept of "glucose toxicity" many years ago, and I don't think a lot of practitioners are aware of it.
this seems like a rather reasonable solution - finding something the patient CAN do, rather than just shaming/blaming him for 'noncompliance' That place where the individual meets the best practice guidelines is really the point where the art and science of healing come together....and change can occur. If we are not careful to be attentive at this point, the patient often ends up labeled as 'non compliant', and becomes less engaged with providers and ultimately more difficult to treat in the future. There are some folks who are concrete thinkers or just plain stubborn, but not as many as you'd think.
A 4cm tumor with malignant cells on the biopsy. Why not a stress test and possible cardiac cath depending on stress results? Delaying the surgery for a cancer based on the rationale of "controlling the blood sugars" is frankly absurd. Diabetes isn't the killer; the sequelae of the disease are. (i.e. coronary artery disease, peripheral vascular disease, renal issues, etc.) Sounds like the patient needs pre-op tattoing of the lesion and a laparoscopic resection of the tumor. Put him in the ICU and implement strict glucose control post op. The patient is a known non-compliancy problem. What happens when 3 months elapse and his A1C is 12?
As long as the patient gets the appropriate cardiac workup I honestly dont get the reason for the delay. I've never heard of an anesthesiologist cancelling a cancer case because the A1C was too high.
You may like this article.
"Diabetes causes increased infections" = Not straightforward
Everyone: first of all, please note that patient details have been sufficiently disguised so that, frankly, anything specific about colon polyps doesn't apply to the real-life case. The concept is of elective-but-eventually-necessary surgery in the poorly-controlled diabetic.
@Buckeye: Wouldn't you be more concerned about surgical healing and post-op infection (@Nurse K: Your reference did not address infections associated with surgery) rather than merely getting through the surgery? Cancer biology is such that there really are situations where several months' delay does not affect the outcome, despite what the lawyers try to tell the juries. This is not intended to be a medico-legal discussion.
As to what happens if there is no improvement in three months, please see the footnote to the post.
Buckeye - I'm not ALLOWED to schedule an elective OR case in a diabetic without an A1c drawn within the last 3 months under 7.5 (and no, 7.5 doesn't cut it...under 7.5).
When this rule was announced, I said in the surgery dept meeting "what about c-sections? Are you going to make me get them under control?" ;)
grrrrrr..........
"Cancer biology is such that there really are situations where several months' delay does not affect the outcome"
And their are situations where it does delay the outcome dino. How are you going to tell which from which? You can't detect micromets. Sorry, I agree with buckeye on this one. Test for underlying CAD and aggressive blood sugar control post-op.
Laparoscopic resection= fewer wound healing/infectious complications, even in a diabetic. If the patient was suffering from refractory attacks of debilitating biliary colic I would suggest the same protocol; cardiac eval, strict peri-op glucose control, elective surgery. Laparoscopy in many respects is rendering the medical literature on post op wound infections somewhat obsolete. Case in point; appendicitis. Open appy carries a wound infection rate of 10-30% depending on whether there is perforation/abscess present. Laparoscopy basically eliminates superficial infections. I've got a series of over 150 appies (all comers, perforated, simple, gangrenous, etc) with no infectious complications....Just an alternative point of view.
Actually, though this isn't necessarily the first thing you could do, it's IMHO absolutely right on the money.
You can deal with trying to get him onto oral meds later, but your goal right now is to get his sugars under control so he doesn't get a wound dehiscence with a roaring post-op skin infection or peritonitis. You found something you both could work with.
And to whoever asked, his out of control sugars are already damaging his blood vessels, and causing scary things to happen with his lipids. He will almost certainly gain some weight, but that's not his biggest concern right now.
Hallelujah.
I agree with Buckeye on this one. I take care of patients all the time with horribly controlled diabetes and surgical post op. First of all, if the patient is asymptomatic, has no known, CHF, CKD, or stroke, for a nonvascular surgery, I wouldn't not even recommend stressing the guy.
Say you stress him. Then you find a lesion that is stented. You put the poor guy on Plavix for a year. No surgeon will operate on the guy with Plavix. So you take him off plavix for a week perioperatively. The guy clots off his stent and gets an MI.
You've done him no service.
In the absence of angina and the absence of the factors stated above, surgery is indicated. No waiting. I would be more worried about his albumin state than I would his diabetes.
You can always put the guy on an insulin drip perioperatively.
My opinion. I wouldn't delay surgery for uncontrolled diabetes as the reason
I also CANNOT swallow pills. Since I can swallow food, what I do is chew up a mouthful of food, and then pop the pill into my mouth and poke it into the middle of the chewed up foodball, and presto. Kinda weird, but it works for me.
Random "just cuz" question---Between smoking and uncontrolled diabetes, which is more predictive of bad post-op healing? When I was on neurosurgery, no docs would fuse anyone (lumbar/cervical spine) who was a smoker, for instance. I never heard anyone mention anything about not operating on someone because their diabetes was uncontrolled.
If the dood was scheduled for the same surgery, had no diabetes, but was a 2 PPD smoker (with a normal cxr and O2 sats), would you have approved him?
AHA guidelines happy:
" In patients who have undergone PCI, clopidogrel 75 mg daily should be given for at least 1 month after bare-metal stent implantation (unless the patient is at increased risk for bleeding; then it should be given for a minimum of 2 weeks"
anon, either you read old guidelines or you intentionally left out the updated ones. Regardless, here are the current guidelines:
For all post-PCI patients receiving a drug-eluting stent (DES), clopidogrel 75 mg daily should be given for at least 12 months if patients are not at high risk of bleeding. For post PCI patients receiving a BMS, clopidogrel should be given for a minimum of 1 month and ideally up to 12 months (unless the patient is at increased risk of bleeding; then it should be given for a minimum of 2 weeks). (Level of Evidence: B) (Modified recommendation [changed text])
Now, I'm not sure how I as a comprehensive care doc can tell a cardiologist that if the patient needs a stent, that he HAS to put a bare metal stent in. What you risk by sending the guy to the cath lab is one year of plavix, at which point the patient is mentally incapacitated by knowing he has cancer and can't get it cut out. And if he does, coming off his plavix for two weeks could potentially induce a major heart attack and death.
I would take my chances in a non cardiovascular surgery and an asymptomatic patient with out CHF, CKD or history of stroke and I would go to surgery without further evaluation.
I don't see why insulin is such a no-no. If he's experienced with insulin and willing to adjust his insulin dose to what he eats, then it doesn't necessarily cause weight gain. In fact he may feel so much better with a lower A1c that he will get more exercise.
"Now, I'm not sure how I as a comprehensive care doc can tell a cardiologist that if the patient needs a stent, that he HAS to put a bare metal stent in"
Actually it's called sitting down with the cardiologist and surgeon and setting up a plan. This would involve the undestanding of only stenting critical lesions with a BMS and frankly only cathing if the p-thal/dobutamine stress echo showed a concerning reversible lesion. HgBAIC of 13% says to me this is a poorly controlled diabetic who likely has CAD. "Ideally" went out the window a long time ago with this patient. It's all about maximizing the chances of getting this guy though the surgery. "Ideally" this guy should be presented at tumor board with the surgeon, med onc, and dino. But that would involve dino actually stepping foot into a hospital.........
What part of "Patient details have been disguised" doesn't register with you micromanaging Monday morning quarterbacking morons?
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