Like many practicing general surgeons I read with interest the recent Finnish paper published in JAMA that attempted to challenge the long held surgical dogma that the best treatment of acute appendicitis is cold hard steel. The paper itself, in terms of design, was beautiful. This was no retrospective review of a series of case studies. This was a rigorously conducted multi-center randomized controlled trial that assigned 530 patients over the course of 3 years into either surgical or non-surgical treatment arms:
Interventions. Patients randomized to antibiotic therapy received intravenous ertapenem (1 g/d) for 3 days followed by 7 days of oral levofloxacin (500 mg once daily) and metronidazole (500 mg 3 times per day). Patients randomized to the surgical treatment group were assigned to undergo standard open appendectomy.
Main Outcomes and Measures/ The primary end point for the surgical intervention was the successful completion of an appendectomy. The primary end point for antibiotic-treated patients was discharge from the hospital without the need for surgery and no recurrent appendicitis during a 1-year follow-up period.
The results revealed entirely expected findings. Surgical removal of the appendix had a 99.6 percent success rate. Medical treatment, on the other hand, failed 27.3 percent of the time (i.e., patient needed to undergo subsequent salvage surgery within the one year follow-up period). To an actual general surgeon like myself, the findings are completely unsurprising. The stupefying part has been the response of the general public to the study.
In the New York Times we have Gina Kolata, misleadingly titling her article: “Antibiotics Are Effective in Appendicitis, Study Says.” Actually, no. Over a quarter of patients failed the proposed alternative treatment and required eventual surgery. That’s bad. Like, what if someone wrote a paper saying that you could alternatively treat a heart attack simply with pain medications and a beta blocker and “only” 27 percent of patients would die within a year? Would this be cause for celebration? There are so many issues and problems with this paper I can only address them all using bullet points.
In patient hospital stay and inconvenience to patients. When I do laparoscopic appendectomy on my patients, most are discharged home within 12 to 24 hours. The non-surgical treatment arm of the study spent three entire days in the hospital receiving IV ertapenem. Then they went home on a seven-day course of oral antibiotics. What is the cost of this? What is the effect on antibiotic resistance and development of hospital-acquired C. difficile colitis? What impact does this have on hospital bed congestion? Would you want to sit around doing nothing in a hospital room for three days?
Surgical technique. The authors of the study state that the reason they chose open appendectomy over laparoscopic surgery was that it was more representative of the surgical options worldwide, accounting for third-world countries without advanced laparoscopic capabilities. That’s all well and good, but the third world is rapidly catching up with the west. In the United States, 80 percent of appendectomies are performed laparoscopically, and this number will only continue to rise as older surgeons from the pre-minimally invasive era retire. Laparoscopic appendectomy is well tolerated by young and old. I don’t restrict activities after surgery. Most patients are back to work/exercise routines within a week. No one goes home with antibiotics after uneventful appendectomy. Infectious complications and pain perceptions are much lower compared with the open approach.
Non-inferiority. The paper claims success because the medical treatment arm did not meet criterion for non-inferiority compared with appendectomy. And what was that criterion? Oh, it was a prespecified, arbitrarily chosen number of 24 percent that the authors just sort of picked out of thin air. Quite the low bar they have set. As long as we don’t fail more than 25 percent of the time we can claim victory! Of course, the actual result of a 27 percent fail rate quoted in the paper exceeds the arbitrarily defined cutoff of 24 percent. But, standard deviation, margin of error, p-values, confidence intervals, etc. (head explodes). Plus, “non-inferiority” is a bullsh!t, Orwellian-sounding term.
Follow up limited. Patients treated medically in the study were only followed for a year. I guess that’s fine if you are talking about a 88-year-old guy with CHF and dementia. But what about the 22 year old? The 41 year old? Those patients presumably have a lot longer to go than one additional year of life. Not everyone will develop recurrent appendicitis, true. But what about other complications? I took care of a patient not too long ago who was managed expectantly with antibiotics for appendicitis a number of years ago. She presented with a bowel obstruction. She had never had surgery before. I had to explore her laparoscopically and the point of obstruction was due to a band of omentum stuck down against the cecum, creating an internal hernia. Underneath the omentum was a scarred, thickened, inflamed appearing appendix. I took her appendix out and lysed the adhesion. What about the rare case of appendiceal mucocele or even carcinoma that presents as “uncomplicated appendicitis”?
This paper ought not to change evidence-based best practice guidelines. For uncomplicated acute appendicitis, the best treatment recommendation remains laparoscopic appendectomy, generally to be done within 24 hours of presentation to the hospital. There is a role for non-operative therapy. Some patients are simply not fit for surgery due to multiple co-morbidities. Some cases are equivocal for appendicitis, even after a thorough pre-operative work-up. Some patients are fully anticoagulated with irreversible blood thinners and surgery has to be either delayed or deferred altogether. Sometimes a certain kind of patient will just adamantly refuse surgical intervention. But these cases ought to be the exception to the rule.
The lesson from the Finnish study unequivocally ought not to be: “We need to start presenting non-operative therapy as a viable, equally efficacious treatment option to patients we see in the ER with acute appendicitis.” The paper actually makes the opposite argument than the one its authors would imply. Appendicitis remains a surgical disease. The best treatment is to get that useless, swollen, gnarled, rotten colonic appendage transferred from inside your body to the bottom of a metal kidney basin.
Jeffrey Parks is a general surgeon who blogs at his self-titled site, Jeffrey Parks, MD.
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