Gallbladder surgery goes back to the future in China

Chinese surgeons claim taking out just the gallstones without removing the gallbladder works well for most patients.

There were 65 patients with gallstones, 61 of whom underwent successful minimally invasive surgery for removal of just the stones leaving the gallbladder in place. The other four patients had laparoscopic cholecystectomies for various technical reasons. After an average follow-up of 26 months, the stone recurrence rate was 4.9% (3 cases).

Not mentioned in the abstract but noted in the methods section of the full article is that all patients were given a 3-month course of ursodiol postoperatively. The authors said it "adjusts the abnormal lipid metabolism in the gut-liver axis and prevents stone recurrence." This statement contains some truth up until the word "and." It's not clear how a short course of ursodiol would help.

Before the advent of laparoscopic cholecystectomy, doctors tried dissolution with ursodiol as a primary treatment. It worked 30-80% of the time for pure cholesterol stones, not those that were pigmented or calcified. About 50% of the time the gallstones recurred after the medication was stopped if the follow-up was long enough, that is, at least 7 years. [I had to go back to 1988 for this reference.]

Well over 100 years ago when open gallbladder surgery was first attempted, surgeons soon learned that removing the stones was inadequate treatment due to a high rate of recurrence.

Since the gallstone removal procedure involved general anesthesia and laparoscopy with two 10 mm and two 5 mm ports anyway, it makes absolutely no sense to just remove the stones. Most laparoscopic cholecystectomies are done with one 10 mm and three 5 mm ports so there is one less large incision which decreases the risk of postoperative hernias.

Here are some more issues.

Preoperatively, only 26 of the patients in the series had biliary colic. Gallstones with "atypical upper gastrointestinal symptoms" were present in 34, and 5 had no symptoms. Surgeons in the US generally would not have operated on patients in the latter two categories.

No mention was made of the duration of the operation, which involves laparoscopy with the 4 ports as noted above, insertion of a choledochoscope into the gallbladder, grasping the stones with a basket an unstated number of times, irrigation, and suture closure of the gallbladder wall.

The authors also that said except for the three recurrences of stones, gallbladder function was normal postoperatively. This was determined by ultrasonography after a fatty meal which took place every 6 months postop.

The three reoperations were done when stones were found by the ultrasound. Of those three, the authors said, "One patient remained asymptomatic, 1 patient experienced biliary colic, and the other patient had non-specific upper gastrointestinal symptoms (flatulence and dyspepsia)."

I don't see this procedure catching on here in the US. Do you?

UPDATE 3/25/14: See a follow-up post on this subject here.

"Medical errors kill hundreds of thousands each year in the US"

How about that headline?

It appeared on RT.com, "the first Russian 24/7 English-language news channel which brings the Russian view on global news."

The story, which originally ran in November of 2013, was resurrected again on Twitter yesterday. It's subject was a paper that claimed as many as 440,000 patients die from medical errors in the United States every year.

Back in September, I criticized the study because it assumed that every death was both preventable and caused by a medical error. Neither assumption is correct. It also extrapolated the doomsday figures from only four other papers describing just 38 deaths.

In that post I said, "Inflating the incidence of these problems does nothing but further erode the already shaky confidence of the public in the medical profession. And creating the impression that such events are totally preventable leads to unrealistic expectations and unachievable goals."

So why am I bringing this up again?

Take a look at a few of the comments from the RT.com story [printed verbatim]:

Old news, as many as a million die each year cause of doctor errors. Thats why their malpractice insurance is so high. Legal unintentional homicide.

It's convenient to claim such deaths are errors but a great many are deliberate. They know such incidents will not be investigated as crimes. It's very easy to conceal a murder if no one is looking. The medical system is completely corrupt.

if they'd stop getting high in med school and pay more attention maybe this wouldnt happen. then there is their attitudes. Heaven forbid anyone needs medical care, that's for sure.

According to CDC, medical errors is not even a category of death, but they published research that indicates drunk drivers kill about 10,000 yearly. If that is correct, then doctors kill almost twice that many every hour of every day -. MADD should be mad about DEADLY DOCTORS. You are 40 times more likely to be killed by a deadly doc than you are by a drunk driver. And yet - where is the "funding" for this deadly phenomena?

I know those who comment on the Internet usually do not represent the views of rational individuals, but it infuriates the hell out of me that the 440,000 deaths from medical errors estimate, which is clearly wrong, is repeatedly trumpeted all over the place and so readily believed.

By the way, the paper appeared in the Journal of Patient Safety, which recently underwent an editorial change due to a kickback scandal involving former editor Dr. Charles Denham. That's another story (here).

Do doctors and hospitals make mistakes? Yes. Can we improve? Yes. Does it help to exaggerate the magnitude of the problem? Emphatically, no.

Single-incision vs. standard 4-port laparoscopic cholecystectomy: Part 2

Here's another paper that shows why reading only an abstract can sometimes be misleading.

A prospective trial (abstract here) of 49 patients randomized to single-incision laparoscopic cholecystectomy (SILC) vs. 51 who had standard 4-port laparoscopic cholecystectomy (LC) found that average operative times were 63.5 ± 21.0 minutes for the SILC compared to 43.8 ± 24.2 minutes for those who had LC, and hospital charges were also more than $4000 higher for the SILC patients—both significant differences with p values < 0.0001.

Medical and surgical supplies were the major factors contributing to the increased charges for SILC.

Other than a significantly larger number of females in the SILC group, the patients were similar in baseline characteristics.

Other important considerations such as postoperative pain, hospital length of stay (an average of 24 hours or less for both operations), use of analgesics, cosmetic appearance of the wounds, rates of incisional hernia, and quality of life were similar. Average follow-up was 16 months in both groups. The authors concluded that there was no advantage to SILC.

Since this paper supports my bias against single-incision surgery, I was going to tout it as yet another negative paper like a recent meta-analysis (here) from a group in Croatia showing absolutely no advantage for SILC.

But this sentence from the "Methods" section of the paper foiled my plan. "Before partaking in the study, each surgeon developed his or her SILC technical skills in a laboratory setting and demonstrated proficiency during 5 SILCs under the supervision of a surgeon with experience on more than 50 SILC cases."

This was not mentioned in the abstract.

Are you surprised that a surgeon that might take longer to do SILC, an operation done only 5 times before, than LC, which each of the surgeons had probably done hundreds of times? Although the mean operative duration was longer for SILC, it is a "straw man" in statistical parlance. This may not detract from the rest of the results but certainly has to be considered.

As noted by the authors, the study was underpowered (that is, there weren't enough patients) to detect differences in some of the other outcomes due to difficulty recruiting subjects.

Of 946 patients offered enrollment in the study, only 103 consented. Patients declined to participate either because the surgeon explained that he had done more standard LC procedures, or the patients opted for the SILC because of its supposed cosmetic advantage.

The authors, based at Northwestern University Medical School in Chicago, should be commended for their honesty in explaining their inexperience with SILC to potential subjects of the trial and wonder if other surgeons who perform SILC do this.

This paper also highlights the problems associated with attempts to conduct randomized prospective studies involving new surgical procedures.

Bottom line: The extra costs associated with SILC are not worth it.

Part 1 of this 2-part series on SILC appeared on Tuesday, 2/18.

Universal medical licensing for doctors—a good idea that will never happen

Some well-intentioned people at the Center for American Progress say that the concept of individual state medical licenses is outdated, and states should recognize each others' licenses.

On the Health Affairs Blog, they listed many convincing reasons for this plan such as the streamlining of some requirements—many of which are unique to each state, the consolidation of such things as background checks and paperwork, decreasing costs to physicians, the fact that individual licensing has hindered the development of telemedicine, difficulty in credentialing physicians trying to help out in disasters, delays at best averaging 2 to 3 months to obtain a license in another state, and others.

On Twitter the idea was endorsed by Dr. Ashish K. Jha, a health policy researcher at Harvard. However, he wondered whether state boards would tolerate the loss of income. To me, the answer is simple. No.

To give you an idea of the magnitude of income the states receive, consider these figures.

According to the Federation of State Medical Boards (FSMB) as of 2012, there are approximately 878,000 MDs and DOs with active licenses in the United States. This includes 142,423 (16.8%) who have active licenses in two states, and 50,454 (5.9%) with licenses in three.

The average cost of a medical license and yearly renewal in each state is about $400. I was unable to determine exactly how many states require yearly renewal, but a spot check suggests that it is well over half.

I'll do the math. Using the FSMB data, there are about 192,000 doctors with active licenses in two or three states. If states recognized valid licenses from other states, they would lose about $100,000,000 in yearly revenue. (142,423 docs would no longer have to pay for one additional license and 50,454 for two additional licenses [50,454 x 2] x $400.) And to yield all medical licensing to the feds, the states would lose another $351,200,000 (878,000 x $400) every year.

The state medical boards probably couldn't even make the decision independently. Another figure which I could not obtain is how many states funnel medical licensing income into their general funds instead of using the money to investigate complaints about doctors. I know some states do so for sure, including Connecticut and Texas.

It seems many of these fees are really taxes disguised as licensing costs.

Yes, universal medical licensing is a great idea, but the states will never give up this money.

Single-incision vs. standard 4-port laparoscopic cholecystectomy: Part 1 of 2

The saying used to be, "You can get any paper published if you have enough stamps." Now with electronic submission, you don't even need the stamps.

A retrospective study comparing single-incision laparoscopic cholecystectomy (SILC) to standard 4-port laparoscopic cholecystectomy (LC) concluded that "SILC showed no disadvantage concerning risk profiles, operative times or hospital stay."

According to the abstract, 81.7% of the 115 SILC patients had elective surgery vs. 55.5% of the 344 in the LC group. The SILC cohort experienced significantly shorter operative times (70 ± 31 vs. LC: 80 ± 27 minutes) and hospital lengths of stay (3.02 ± 1.4 vs. LC: 4.6 ± 2.8 days), p < 0.001 for both. LC was converted to open surgery in 21 cases vs. none of the SILCs, p= 0.003. Rates of bile leak and incisional hernia did not differ.

Do you see any problems with this study? I do.

The groups were not really comparable because the LC group underwent more emergency operations. That difference is significant with a p value of 0.007—conveniently omitted from the abstract. The preponderance of elective cases likely accounts for the SILC group's shorter operative duration, lower rate of conversion to open, and shorter length of stay. The SILC patients were also a mean of 10 years younger.

The average operative time for the LC patients, 80 minutes, is much longer than the 40 to 45 minutes reported in most other recent series such as this one. In statistical circles, measuring one's pet theory against a false comparator is known as setting up a "straw man." I've written about this before.

This study was done in Germany, where the hospital lengths of stay for both types of surgery are far longer than those seen in the United States where about 90% of patients go home within 24 hours of laparoscopic cholecystectomy.

The authors concluded that "SILC can be regarded as a natural evolution in the era of minimally invasive surgery."

On the other hand "No disadvantage" is another way of saying, "No advantage."

This paper didn't convince me about the value of SILC. How about you?

Part 2 of this 2-part series on SILC appeared on Thursday, 2/20.

Antibiotics instead of surgery for appendicitis? No way

A retrospective study from California claims that the nonoperative management of simple appendicitis may be safe and is worth studying further.

Why am I not convinced? Because every time this subject comes up, the paper purporting to show that antibiotics are superior or even equal to surgical treatment is flawed. The trend continues with the current paper du jour which appears online in the Journal of the American College of Surgeons.

This study looked at the records of over 231,000 patients with uncomplicated appendicitis during the years 1997 to 2008. Only 3236 (1.5%) of those patients were treated non-operatively, and 10.3% of them had either a failure of antibiotic treatment or a recurrence of appendicitis during follow-up with 3% of those having perforations. Mortality rates were very low (appendectomy 0.1%, antibiotics 0.3%) and not significantly different, and hospital charges were similar in the groups matched with propensity scoring. Length of stay was significantly longer for those treated with antibiotics 3.2 days vs. 2.1 days, p < 0.001.

Sounds great, right?

I will not go into detail about the some of the important problems with this paper such as the fact that before the statistical manipulation with propensity scoring, the baseline characteristics of the patients in both groups were significantly different in all but one category. In table 1 of the paper, the number of patients available for follow-up was exactly the same as the number entering the study. That means that not a single patient was lost to follow-up, which is hard to believe since people occasionally move out of state. The reasons that patients did not undergo appendectomy could not be determined from the administrative database used.

Here are the key issues.

The paper was based on discharge diagnoses. Even with the use of CT scans for diagnosis, some cases of what seem to be simple appendicitis turn out to be more extensive at surgery. Had these patients been treated with antibiotics, the results would have been disastrous. And as a paper from the UK reported, administrative databases are notoriously unreliable for use in clinical studies.

The biggest problem with the paper touting antibiotics for appendicitis is that it includes patients over the course of the 11 years from 1997 to 2008. During that time and continuing to the present, the surgical technique of appendectomy has evolved.

If you look at the same database used by the authors (California Office of Statewide Health Planning and Development Patient Discharge), you will find that in 1999, appendectomies were done laparoscopically in 7574 of 36,740 cases or 21% of the time. Fast-forward to 2012, and note the converse—laparoscopic appendectomy was performed in 35,393 (79%) of 44,582 appendectomies.

Why is this important? The average length of stay for laparoscopic appendectomy for simple appendicitis is one day or fewer. This is less than half of the time stated in the comparison with antibiotic treatment.

In the January 2014 issue of the Journal of Trauma, a study reported 345 patients who had a laparoscopic appendectomy for uncomplicated appendicitis. Of those patients, 305 (88%) were discharged home from the post anesthesia care unit. The average time from admission to operation was five hours, and the average time spent in the PACU was just under 3 hours. The reasons that the 40 (12%) patients were admitted were lack of transportation in 19, pre-existing comorbidities in 15, and postoperative morbidity in 6. Only 4 of the patients who were discharged directly from the PACU required readmission. Thus, total complications (postop morbidity plus readmission) numbered 10 (2.8%).

Treating appendicitis with antibiotics also exposes patients to the risks of C. difficile colitis and other side effects of the drugs. The complications associated with laparoscopic appendectomy for simple appendicitis are few, and more importantly, the appendix is gone forever.

The authors concluded: "While the rate of treatment failure was 5.9% in non-operative patients, it was only 0.1% in operative patients. With concerns over controlling 30-day readmission and rising healthcare costs, these shortcomings may be substantial barriers to the consideration of non-operative approaches."

A randomized trial of antibiotics vs. surgery for uncomplicated appendicitis is underway in Finland. Judging from the wording of the abstract describing the trial, the authors are markedly biased toward the use of antibiotics. Despite this, let's hope it sheds some much needed light on this subject.

I don't understand why investigators, especially surgeons, continue to push antibiotics as an alternative to appendectomy. For simple appendicitis, laparoscopic surgery is quick, safe, and definitive.

An ACA fail: One family's saga

The following was written by my daughter, who has a master's degree and should be an ideal candidate for the new world of healthcare coverage.

The Affordable Care Act should benefit people like me. My husband is self-employed, and we have been paying for our own insurance for years now. I looked forward to the ACA marketplace opening up, and hoped that it would provide us with some options for lower-cost insurance. This was especially true after I found out that for our current plan, with a $10,000 family deductible, the premium was going up to $550 per month for 2014, with the addition of our new baby and the expected annual increase.

Searching the ACA website for my state, AccessHealthCT.com, I was happy to see that we qualified for a federal subsidy of $700 per month, and with that, there was an option for what seemed like a similar plan to what we have now. I selected the plan with Anthem BCBS that had a monthly premium of $298.61, with a family deductible of $12,600. This meant we could keep our HSA, and possibly save a lot of money for the year if we did not meet our deductible.

I spent 45 minutes filling out the application, and almost immediately received a letter from Access Health CT saying I had successfully enrolled in the plan I chose, although it did not list the premium on that letter. Ten days later, I had received nothing from Anthem so I called them. I waited an hour to talk to a human, who said yes I was enrolled and just had to pay the first month premium to complete the sign up. 

I would have done this, except that the amount I was told to pay was $2480.46, for the first month and for each month after that. But wait, I said, the premium was listed as $298.61 per month after the subsidy was accounted for. She said the $2480.46 was the amount due from me, having already accounted for the $700 assistance from the federal government. It’s interesting to note that the subsidy amount came through correctly even though my premium was now eight times higher. She said I would have to call Access Health CT to find out what went wrong with the premium.