Appendicitis Management & APPY Trial: Update Course 2016
hosted by Dr. Todd Ponsky · StayCurrentMD
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Appendicitis 11 items
Educational content from recorded physician discussions — not medical advice. Talk to your (or your child's) care team about your situation.
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What the experts said
The APPY trial is a multi-center randomized trial comparing appendectomy to non-operative treatment for non-perforated appendicitis.
The initial working group included Agostino Piero, Nigel Hall, Simon Eaton, Thomas Wester, and several others, with the current group joining about 2.5 years ago.
The first two rounds of funding failed, requiring modifications to sample size calculation and study design to make it more pragmatic.
Appendicitis can be treated without surgery, as demonstrated by experience with complicated appendicitis where patients are treated to completion regardless of perforation severity.
Bob Parry developed appendicitis in Ireland, was treated with antibiotics, and went a full year before having a recurrent bout requiring appendectomy.
In the preference trial, any appendix that has to come out—even if due to parental preference after symptom resolution—must be considered a treatment failure because that reflects real-world practice.
In the preference trial, parents of sicker-appearing children are less likely to choose non-operative management, even if objective measures like white count are similar.
Patients who respond to antibiotics are literally normal the next day, going to school on Wednesday after discharge on Tuesday, whereas laparoscopic appendectomy patients restrict themselves for several days despite no formal restrictions.
The APPY trial is designed as a non-inferiority study because non-operative management cannot possibly be superior to appendectomy, which has a 100% cure rate.
The trial includes patients aged 5 to 16 with suspected non-perforated appendicitis, excluding those under 5 because they frequently have perforation regardless of presentation.
The trial uses broad inclusion criteria without requiring specific Alvarado scores, PAS scores, or imaging findings, allowing surgeons to use their standard diagnostic approach for non-perforated appendicitis.
Exclusion criteria include suspicion of perforation, more than two doses of antibiotics initiated at an outside facility, previous episode of appendicitis treated non-operatively, and systemic disease.
The trial uses central randomization with minimization based on sex, center, and duration of symptoms to maintain balance across these factors.
The protocol was modified to allow patients to go home the next day if doing well, rather than requiring 24-48 hour evaluations at fixed time points, because the original schedule was impractical for overnight enrollments.
If patients are not better after initial therapy, they are given another day, but after 48 hours of IV therapy (by Wednesday morning), it is time to proceed with appendectomy because 3 days in the hospital is too much when the alternative is going home Monday.
The primary outcome is treatment failure defined as an intervention for appendicitis requiring general anesthesia within 1 year in both groups, which essentially compares negative appendectomy versus recurrent appendicitis.
The non-inferiority margin is 20% because polling showed most people consider failure rates in the twenties too high for non-operative management.
The actual failure rate percentage is what matters to parents when counseling, not whether the trial concludes non-inferiority—some parents will accept 26% failure to avoid surgery while others won't accept 2%.
The two negative appendectomies in the operative group had imaging showing secondary signs like fluid but not visualizing the appendix.
Of the 3 early failures in the non-operative group, 2 were due to parental impatience on the morning after enrollment, not giving the treatment a real chance.
As of the presentation, 52 patients have been enrolled: Stockholm 25, Helsinki 7, with Vancouver, Ontario, and Calgary recently receiving IRB approval.
Early results show in the operative group: 4 perforations and 2 negative appendectomies. In the non-operative group: 1 readmitted for abscess, 3 failed early (didn't leave hospital), 4 failed after discharge (within 2-5 days), and 1 recurrence at 6 months.
The reason for limiting antibiotics is that Augmentin is given daily in pediatric offices to thousands of children with sniffles who don't need it, whereas the APPY trial treats an active intra-abdominal bacterial infection.
All recurrences and failures in the non-operative group have had confirmed appendicitis; no normal appendix has been removed yet.
All perforated appendicitis cases are treated with antibiotics, and if complications develop, long-term antibiotics are used until resolution, so treating intra-abdominal infection is different from unnecessary antibiotic use.
The value of the study is knowing the exact failure rates and outcomes to counsel patients who might want to avoid surgery or are in circumstances where surgery isn't immediately feasible, even if non-operative management proves inferior.
No adult literature has examined long-term outcomes beyond one year for non-operative management of appendicitis.
The trial plans to follow the cohort in perpetuity with annual telephone follow-up to determine recurrence rates at 5 years, 10 years, and beyond.
Perforation is defined as a hole in the appendix or a fecolith in the abdomen—irrefutable proof of contamination—and is only an intraoperative diagnosis, not a preoperative one.
The presence of a fecolith is an exclusion criterion in the Midwest Pediatric Surgery Consortium preference trial but not in the APPY trial.
At Nationwide, a separate small population with appendicoliths was allowed enrollment, but that arm was stopped based on the failure rate.
In a cohort of patients with post-appendectomy abscesses, outcomes were relatively equivalent between drain and no drain, but the biggest abscesses and worst patients received drains.
After size-matching to 17.5 cm² (AP versus lateral in axial dimension), there was an advantage to not having a drain.
For abscesses less than 20 cm² (less than 4 x 5 cm), drains are typically discouraged because the advantage is small and drains add an extra anesthetic, procedure, and may increase length of stay.
In adult studies reviewing approximately 300 patients managed non-operatively versus 500 managed operatively, treatment failure trended toward favoring surgical approach, but complications favored non-operative management.
Adult estimates of non-operative management success revolve around 80%, which was integral in developing the sample size for the randomized trial.
Thomas Wester's pilot randomized trial in Sweden enrolled 50 patients, with 24 receiving antibiotics. 22 of 24 (92%) had initial resolution of symptoms, and one patient had recurrent appendicitis.
At 77 patients in the preference trial, 30 chose non-operative treatment (about one-third), with 90% success at 30 days and fewer disability days, earlier return to school, and improved quality of life versus surgery.