Appendectomy outcomes in the modern era

Finally we have some data on the current rate of complications of appendectomy for uncomplicated appendicitis. But that’s not all. This new paper, published online in the journal Surgery, reveals much about the diagnosis, technique, and outcomes of appendectomy in the United States.

Using data from 115 hospitals participating in the National Surgical Quality Improvement Program, researchers at UCLA analyzed the results of 7778 adult patients undergoing appendectomy for simple appendicitis in 2016.

What to do when a normal looking appendix is found at surgery for appendicitis

For patients undergoing surgery with a presumptive diagnosis of appendicitis in Norway and other parts of Europe, the protocol is if the appendix looks grossly normal in the operating room, it is usually not removed.

This approach was mentioned as part of a paper on the readmission of post-appendectomy patients from Oslo University Hospital. Most of the patients underwent laparoscopy based on clinical diagnosis with only 160 having CT scans and 67 having ultrasounds.

Of the 710 patients in the Oslo series, 94% of the appendectomies were done laparoscopically, and 111 had a normal appearing appendix at laparoscopy. The appendix was not removed in 88. The other 23 patients had appendectomies for various reasons, and those appendices were normal at pathology.

The cumulative rate of operating for what turned out to be a normal appendix (88 + 23 cases) was 15.6%, which the authors attributed to “the low use of preoperative CT” due to concerns about radiation exposure. That over 100 patients had unnecessary general anesthesia and surgery was apparently not a concern.

Nonoperative treatment of appendicitis in children: Is it safe?

After writing my 21st post about appendicitis back in November, I swore I would not write about it again for the foreseeable future.

Well, the future is now because investigators from the United Kingdom and Canada just published a meta-analysis including 10 papers and 413 children about the efficacy and safety of nonoperative treatment for appendicitis in children.

They concluded that nonoperative management is effective in 96% of children with acute uncomplicated appendicitis during their initial hospitalizations with just 17 (4%) children requiring appendectomy before discharge. An additional 68 (16.4%) developed recurrent appendicitis later, and 19 of these patients were treated with the second course of antibiotics. The other 49 underwent appendectomy with histologic evidence of recurrent appendicitis.

Another 11 patients underwent appendectomy in the follow-up period for various reasons. In all, 77 (18.6%) patients initially treated with antibiotics eventually underwent appendectomy.

Although the initial hospital length of stay for appendectomy was shorter than that of patients treated with antibiotics, complication rates were similar.

These findings were met with headlines like "Antibiotics, not surgery, could treat appendicitis in children, study suggests" from The Guardian and "Is Surgery Always Needed for Kids' Appendicitis?" from US News.

What are the problems with this paper?

A medical oncologist weighs in on the treatment of appendicitis

It was an interesting fortnight for the debate about the treatment of appendicitis.

On November 1, David Agus, a medical oncologist and Director of the University Of Southern California's Center for Applied Molecular Medicine, had some thoughts about how appendicitis should be treated. He cited the Finnish randomized trial of antibiotics vs. surgery and said a 70% cure rate was good enough.

In a brief article on the Fortune magazine website, Agus wondered why appendectomy "continues to reign supreme." He said it was "because 24/7 we’re taught you have to take it out if there’s appendicitis” and that the healthcare community is "stubborn and pigheaded" [pigheaded means stubborn] and that we focus on treatment instead of prevention.

Antibiotics vs. surgery for appendicitis: Critique of a meta-analysis

A meta-analysis can be useful when looking at a topic that has been studied by several different groups of investigators. The pooling of data from different published papers can sometimes bolster a conclusion about the effectiveness of a treatment.

However, a meta-analysis is only as good as the studies it includes, and the biases of those performing the meta-analysis can color the results.

Last month, a meta-analysis concerning antibiotics vs. surgery for the treatment of uncomplicated acute appendicitis by investigators from Nottingham University Hospitals was published in the World Journal of Surgery.

The authors concluded that “antibiotic therapy represents a safe, efficacious and viable treatment option for the treatment of uncomplicated acute appendicitis.” I disagree.

Five randomized trials involving 1430 subjects were included in the meta-analysis. After one year of follow-up, the efficacy of treatment for those receiving antibiotics was 62.2% compared with those undergoing appendectomy whose treatment efficacy was 88%. Depending on the inclusion or exclusion of a particularly weak study there was said to be a 39-52% risk reduction for complications in the antibiotic group.

This meta-analysis has so many problems that it is hard to know where to start.

Appendicitis: Continuing debate about treatment

The other day on Twitter, Kenny Goldberg (@kghealth), a health reporter at KPBS News in San Diego, asked me, "Why all the stories on antibiotics vs. surgery for appendicitis? Are appendectomies inherently dangerous?" My answer was "Great question. The answer is a resounding 'No.' The complication rate is very low."

Yet the papers keep coming.

A new systematic review of all the randomized controlled studies on appendicitis found important shortcomings in all of them. Here are a few:

Bias in selecting patients was a problem in all six of the studies reviewed. Diagnostic criteria for inclusion in the studies were not standardized. Some of the studies enrolled patients with clinically diagnosed appendicitis only. Since some patients may not have had appendicitis, they would probably have improved regardless of how they were treated.

Patients were treated with a variety of antibiotics, Since most of the studies were done in Europe, open appendectomy was the more common surgical intervention. Laparoscopic appendectomy results in fewer complications and shorter lengths of stay than the traditional open procedure.

Follow-up in five of the six studies was one year with only one study following patients as long as a median of 17 months. Rates of recurrent appendicitis necessitating appendectomy ranged from 24% to 60% with an average of 35.4%. What will the recurrence rates be at 3 years? 5 years?

The authors concluded that although more evidence for treating appendicitis with antibiotics has emerged, the comparative effectiveness of that strategy is still unknown. They recommend that patients should be enrolled in clinical trials or registries to help answer this therapeutic question.

The second recent paper involves two issues I have commented about many times—research and medical reporting.

It's a study of 102 pediatric patients between the ages of 7 and 17 with uncomplicated appendicitis as judged by CT scan parameters. After informed consent was discussed, parents were permitted to choose the therapeutic arm, antibiotics or laparoscopic surgery.

Of the 629 patients who presented with acute appendicitis during the study period, only 102 (21%) met the study's inclusion criteria of whom 37 were selected for antibiotic therapy by their parents.

During the median follow-up period of 21 months, 9 (24.3%) patients initially treated with antibiotics had to undergo appendectomy.

I blogged about this study's preliminary results when they were published back in 2014. If you would like more details about its limitations, read that post.

The inadequacies of medical reporting on this paper were rather glaring. Under the headline "Not all kids with appendicitis need surgery. Antibiotics can work just fine," the Boston Globe's new website Stat News said the following:

“'Their parents began to question whether they needed surgery [for appendicitis],' said [lead author] Dr. Peter Minneci, a pediatric surgeon at Nationwide in Columbus, Ohio. Minneci decided to answer the question with a controlled study." Sorry folks, this wasn't a controlled study.

The New York Times reported: "The surgery group had more complications and two of those who chose antibiotics had to be readmitted to the hospital for appendectomies in the first 30 days." This is misleading because although 5 of 65 patients in the surgery group had postoperative complications compared to none of the 9 who eventually had appendectomies in the antibiotic group, the difference was not statistically significant (p = 1.0, Fisher's exact test).

But the most interesting thing about this paper was an entire page explaining why allowing parents to select the therapy was a better method than randomizing patients to one group or the other. It's very clever and must be read to be appreciated.

Here is an excerpt: "The patient choice design allows a therapy to be aligned with the preferences of the patient and his or her family, thereby minimizing the potential negative effects of preferences."

I don't know about you, but if I or anyone in my family had appendicitis, my preference would be for a laparoscopic appendectomy.

Is do-it-yourself surgery the future of medicine?

Once in a while, I read something on the Internet that is so silly, so outrageous that I can't help myself. I must speak up.

Such a situation occurred a few days ago when I came across an article called "DIY [do it yourself] Surgery: The Future of Medicine?" on a website called FastCompany.

An "interaction designer" named Frank Kolkman has created a robotic Open Surgery Machine which he proposes could fill in need when "middle-class" US citizens who have no access to healthcare require surgery.

My favorite line from the article is an explanation of what Mr. Kolkman's robot can do. "It's designed to perform simple surgeries like laparoscopic surgery in which three or more small keyhole incisions are made to allow a surgeon to operate inside a part of the patient's body after inflating it with CO2."

He proposes that "appendectomies, prostate operations, hysterectomies, and also colon and general inspections" could be done.

Questions about antibiotics vs. surgery for acute appendicitis

A study from Finland suggesting that antibiotics may be a viable alternative to surgery for acute appendicitis has created a stir. As you might have expected, I had some concerns about the paper which you can read in my blog post here.

On Twitter, many surgeons have commented on both the paper and my post. Several interesting questions come to mind.

Based on this and other similar studies, is the treatment of acute appendicitis with antibiotics now a mainstream alternative to surgery?

Should surgeons now mention the Finnish study results during their informed consent discussions with patients?

Antibiotics for appendicitis? No thanks

The long-awaited Finnish randomized controlled trial of antibiotics vs. surgery for appendicitis was just published in JAMA. Depending on your perspective, 73% of patients were successfully treated with antibiotics or 27% of patients failed antibiotics and needed surgery.

The good news is that it was a large multicenter study involving 273 patients randomized to surgery and 257 to antibiotics. Patients included in the study had uncomplicated appendicitis as diagnosed by CT scan.

The bad news is that the paper has many limitations.

Of the patients who underwent appendectomy as the primary treatment, only 15 (5.5%) had laparoscopic surgery. The authors state that open appendectomy was selected as the protocol operative technique because laparoscopic instruments may not be available worldwide and apparently many surgeons in Finland are not experienced in performing laparoscopic appendectomies.

Surgery in space: I foresee problems.

The astronauts are halfway to Mars when suddenly one of them develops abdominal pain and requires surgery. What will they do?

According to NASA, a miniature robot capable of assisting in surgery has been developed, tested in pigs, and is soon to be trialed in a weightless environment. The robot, which weighs less than 1 pound, can be inserted into the abdomen via the umbilicus and controlled remotely.

The press release from NASA said types of operations that the robot would be capable of performing were "emergency appendectomies, emergency cholecystectomies, emergency perforation of gastric ulcers [sic], and intra-abdominal bleeding due to trauma." NASA meant to say "repair of perforated gastric ulcers." Not surprisingly, many science reporters for media outlets, for example, SFGate and WiredUK, did not notice the error. New Scientist also missed it, but at least published a later correction.

However, even the famous da Vinci robot is incapable of performing surgery on its own.

The original idea was that a surgeon on the ground would direct the robot's movements, but that will not be possible for two reasons. In deep space, the time lag between the earthbound surgeon's actions and the robot's response would be too long, and a recent article about remote-controlled drone crashes highlighted the problems that can occur when links are lost or computers malfunction.

The plan is to train the astronauts to perform minimally invasive robotic surgery on each other. What could go wrong?

A lot.

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.

Choosing antibiotics for appendectomy and cholecystectomy: Are "big guns" needed?

An emergency medicine physician asked me to comment on the use of antibiotics in patients having surgery for acute appendicitis and acute cholecystitis. He said in hospitals where he has worked in three different areas—New York, Miami and San Francisco—surgeons are using Imipenem for cholecystitis and Zoysn for appendicitis.

He wondered why those drugs were chosen and offered a few theories. They are as follows:

1) Surgeons are trying to avoid resistant bugs, so they’re using bigger guns

2) There is more pressure to reduce post-op complication numbers, so they’re using bigger guns

3) It’s easier to give one antibiotic to cover multiple bacterial types, instead of, say, cipro/flagyl or cefoxitin/flagyl

4) Patients do better with these big gun antibiotics

5) Residents are being taught incorrectly, and are just developing bad habits

Yes, it is mandated that everyone needs a dose of prophylactic antibiotics within an hour of surgery for appendicitis and cholecystitis. Of course, there are nuances.
 
Appendicitis is a disease involving an inflamed, eventually infected appendix so the use of antibiotics is possibly therapeutic and not simply prophylactic.
 
For acute cholecystitis, a similar argument can be made. The problem here is that it is often difficult to tell acute cholecystitis (with possibly infected bile) from biliary colic (pain caused by a gallstone impacted in the neck of the GB) without infection. Sometimes the GB ultrasound says acute cholecystitis, the surgeon says acute cholecystitis and the path report says chronic cholecystitis. There are many other permutations of those three observations. (e.g., US-biliary colic, surgeon-biliary colic, path-acute cholecystitis, etc.)
 
Note: I do not routinely culture peritoneal fluid in appendicitis or bile in cholecystitis because by the time the culture report comes back, most patients have been home for two or three days. There is evidence to support not culturing either fluid.
 
Honestly, I’m not so sure that people with early acute appendicitis really need antibiotics. Unless the appendix is perforated, I use only one preop dose. There are also similar differences in the imaging reports, surgeon description and path reports for this disease too.

I doubt that patients with biliary colic benefit from antibiotics either. The problem is that one may not discover that acute cholecystitis is present until one is in the abdomen. The same issue occurs with appendicitis where an unsuspected perforation may be found at surgery.

At least for now, at least one pre-op dose of an appropriate antibiotic seems reasonable.
 
Where I practiced for the last few years, we did not use Imipenem for GBs and only occasionally is Zosyn used for appys. Most of us used Unasyn for both except in the penicillin-allergic patient. For that patient, we used Levaquin and Flagyl. The problem with the latter two drugs is that they each are supposed to be infused over an hour. This is not always possible because the surgery may be started within an hour in certain circumstances, such as when an operating room happens to be vacant and the patient is ready to go. It’s a rare event, but it does happen.
 
There is no evidence that patients with either disease, who usually present from home, have resistant bacteria, and postoperative complications, especially infections, are not common with either disease. There is no evidence that patients do better with “big gun” antibiotics. In fact, most of the evidence that prophylactic antibiotics are even needed in these two operations comes from the pre-laparoscopic era. Wound infections are extremely uncommon with laparoscopic appendectomies and cholecystectomies. This is probably due to the fact that the wounds are small and in most cases, the specimen is removed in a plastic bag so the infected organ does not touch the subcutaneous tissue.
 
If residents are being taught to use “big gun” antibiotics for these two diseases, I agree it’s incorrect. There is little hope of changing this.

It is similar to the unfounded practice of giving everyone who is NPO a proton pump inhibitor, which I wrote about here. There is no scientific rationale for it. Yet everyone does it, and no amount of discussion will convince people to stop.

[Note: A version of this post appeared on General Surgery News a few weeks ago. The version above is better because I thought about it more.]

Single-incision laparoscopic surgery: What are the indications?

My answer is “None.”

There is no compelling reason to perform single-incision laparoscopic surgery (SILS).

Take cholecystectomy, for example. The three 5 mm incisions in the upper abdomen done for standard laparoscopic cholecystectomy are nearly painless and, after a few months, almost always become invisible. The umbilical incision is larger and does cause pain, but the incision for SILS is generally 50% larger than that of standard laparoscopic cholecystectomy and likely to be just as painful if not more so.

For appendectomy, the same reasoning applies regarding the two 5 mm incisions and the umbilical incision. Not only is the umbilical SILS incision larger, one recent paper reports that it results in more postoperative pain too.

The ergonomics of SILS leave a lot to be desired as well. Since the instruments enter the abdomen so close to each other, it is difficult to triangulate them. Obtaining the critical view of the structures in Calot’s triangle is more difficult. It certainly is hard to imagine that SILS is safer for the patient.

There has not been one study convincingly showing superiority of SILS over conventional surgery for any outcome. It will be a challenge to show that compared with multiple-port surgery, SILS shortens length of stay, decreases pain or even has a better cosmetic result after six months.

Small pilot studies of robotic SILS are surfacing. The robotic method offers the possibility that triangulation is slightly improved. But increased costs and longer operative times negate that minor technical gain. What’s more, triangulation is even better with 4-port surgery.

I propose the following:

If SILS had been invented first, papers extolling the safety, ease and comfort of multiple-port surgery would be appearing and everyone would be jumping on the bandwagon to offer it to patients as a better procedure.

Feel free to comment. And don’t ask me if I’ve done a SILS case. The answer should be obvious.

For a more extensive review of single-port vs.standard laparoscopic cholecystectomy, read this paper. Thanks to @anblog84 for sending it to me via Twitter.

Note: This blog appeared yesterday on General Surgery News.

Single incision laparoscopic surgery for appendicitis may not be better

I don’t usually like to review papers that have only been published in abstract form or orally presented because complete data are not available for analysis. But I’m going to make an exception here because a recent paper presented at the American College of Surgeons annual meeting in October and featured on page 1 of Surgery News supports one of my many biases.

Researchers at the Chinese University of Hong Kong performed a trial involving 200 patients undergoing laparoscopic appendectomy randomized into two groups, conventional 3-port [3P] and laparoscopic single-site access [LESS]. The 3P approach uses 3 small incisions to insert the scope/camera and instruments while the LESS uses a single incision at the umbilicus with the scope/camera and instruments all inserted via the one incision.

Guess what? LESS was not only harder to perform [due to the inability to triangulate the instruments which are too close to each other] but it also caused significantly more postoperative pain.

Although LESS theoretically might result in a better cosmetic result because the only incision is in the umbilicus, the 3P procedure results in one scar in the umbilicus and two 5 mm scars in the lower abdomen. The two 5 mm scars are often invisible several months after surgery.

This study is one of the few large randomized trials on any type of single incision surgery and may be the first to show that LESS is inferior to the current standard. Because of their findings, lead author Dr. Anthony Y. B. Teoh said that his group “reverted to the three-port procedure” for patients presenting with appendicitis.

I previously blogged about a small study extolling the virtues of single-port robotic cholecystectomy, which purported to show [but did not] that it was better than the standard laparoscopic method.

Will there be more disillusionment with single-port surgery as larger and better designed studies emerge?