Starting in January 2016, CERTAIN Investigators will begin work on the recently funded clinical trial “Comparison of Outcomes of Drugs and Appendectomy.” This large randomized trial compares appendectomy to antibiotics for the treatment of appendicitis. Before the first patient can enroll in the trial, the study team will complete the final research protocol. The research protocol describes in great detail the design, methods, and evaluation of study data serving as the blueprint for each site participating in the study.
Part of the study protocol includes plans to make sure patients in the study are safe and that those enrolled in both treatment arms (antibiotics or surgery) have a good chance for the treatment to work. If we see early on in the study that there is a concern for safety or the effectiveness of an intervention is poor, we can stop some parts of the study. To do that, we need to pick a "stopping rule" so that we stop enrolling some patients when the success rate in that group falls below a certain number. We will use prior research, expert opinion, and most importantly, patient voices to help guide us for what should be considered “stopping rules.”
In some people with appendicitis, a small stone, called an appendicolith, blocks the base of the appendix. This stone may cause the appendix to be inflamed and may also make it less likely that antibiotics will work. Some doctors believe that antibiotics will fail so often in patients with stones that they shouldn't even be offered antibiotics. The problem is that we know some people with stones can be treated successfully with antibiotics, and we don't really know yet how often people with stones will have a good result with antibiotics. Is it 100% of people with stones who can avoid an appendectomy? Probably not, but it might be 75%, or 50%, or 25% - we don't yet know but want to find out.
Please take our one-minute survey to help us develop the stopping rule for how patients with stones are treated in our study.