Who Says Surgeons Can't Pull Off a Randomized Controlled Trial?

Source: Myers AL, Williams RF, Giles K, et al. Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children. J Am Coll Surg. 2012 In Press; doi:10.1016/j.jamcollsurg.2011.12.026. See AAP Grand Rounds commentary by Dr. Charles Snyder (subscription required).

PICO
Question: Among children with perforated appendicitis, is early appendectomy more cost effective than delayed interval appendectomy?
Question type: Intervention
Study type: Randomized clinical trial

When I taught a formal course in evidence-based medicine to medical school faculty, I can recall that on several occasions some specialists lamented the fact that prospective randomized controlled trials were a virtual impossibility in their specialty.  Surgeons and psychiatrists topped the list.  I was more than happy to show them examples to the contrary. 

It is enormously difficult (and expensive) to carry out a prospective therapeutic clinical trial in patients, and the randomized controlled trial is perhaps the most difficult to accomplish.  When the randomization involves one study group having an operation and the other not, one can certainly imagine patients and families refusing to participate.  In this study, both treatment arms had a surgical procedure, but the timing was different. 

Investigators at the University of Tennessee enrolled 131 children with perforated appendicitis.  Participants received either early (within 24 hours of admission) or late (6-8 weeks after onset, having received antibiotic therapy in the interim) appendectomies.  Their results demonstrated lower costs in the early group, plus an increased rate of adverse events in the delayed group.  So, this study comes down on the side of favoring early surgical intervention. 

Dr. Snyder's commentary in AAP Grand Rounds is really insightful here, especially to us non-surgeons.  In addition to the usual concerns about applying results from a relatively small study at a single institution, he points out additional difficulties in reliably diagnosing perforated appendicitis patients by CT scanning, or even in the OR, plus the view that some authorities might not perform a late appendectomy in such patients, if they had done well with medical management alone.  Now that would be a great randomized prospective trial!

The final word isn't in on the best approach for ruptured appendicitis.  I certainly find it interesting to watch the pendulum of "best practice" swing back and forth, and commend the investigators for a well done study.