Published: Nov 1, 2013
By Charles Bankhead, Staff Writer, MedPage Today

Full Story:  http://www.medpagetoday.com/MeetingCoverage/AAP/42665

ORLANDO — Almost 90% of children with appendicitis remained surgery-free during the first 30 days of a nonoperative protocol, according to results of a small prospective study.

During the initial hospital stay, two of 30 patients required an appendectomy, one because of acute appendicitis and one who had a carcinoid tumor.

Patients treated by the nonoperative protocol had a longer initial hospital stay but returned to school and to normal activities significantly faster that did children who underwent appendectomy, Peter Minneci, MD, of Nationwide Children’s Hospital in Columbus, Ohio, reported here at the American Academy of Pediatrics meeting.

“The 30-day results suggest that nonoperative management is feasible with a high success rate,” said Minneci. “Patients return to school and activities faster and have higher quality-of-life scores.”

Over the past 15 years, eight trials of nonoperative care for adult patients with appendicitis showed that a third of patients had treatment failure during the first year of follow-up. None of the trials controlled for severity of appendicitis, said Minneci.

The trials showed no increase in the rate of perforated appendicitis. The trials also identified risk factors for treatment failure: presence of a fecalith, >48 hours of symptoms, presence of a phlegmon or abscess, and elevated white blood count.

On the basis of the clinical experience in adults, Minneci and colleagues hypothesized that nonoperative management of early appendicitis in children would be feasible and safe and result in a 1-year success rate of 80% to 85%. To test the hypothesis, the investigators performed a prospective, nonrandomized clinical study.

The study involved patients 7 to 18 who had imaging-confirmed early appendicitis, associated with an appendix diameter <1.2 cm and no abscess, phlegmon, or fecalith, as well as a white blood cell count between 5,000 and 18,000. Patients were required to have focal abdominal sonography <48 hours before receiving antibiotics.

Eligible patients (or their parents/guardians) could choose whether to have appendectomy and routine postoperative care or to enter the nonoperative protocol.

The nonoperative pathway consisted of in-hospital observation for at least 24 hours, intravenous antibiotics for at least 24 hours, and no food or drink for at least 12 hours. Patients who improved could begin oral feeding and transition to oral antibiotics, followed by discharge and continuation of oral antibiotics for a total of 10 days.

Patients whose condition worsened or did not improve after 24 hours proceeded to appendectomy.

Patients in the nonoperative group had follow-up visits 2 to 5 days after discharge and after 10 to 14 days. Both treatment groups had follow-up at 30 days for assessment of complications, return to activities, and to complete a quality-of-life inventory and parent report.

Follow-up in nonoperative patients will continue at 6-month intervals for the first year and then annually until age 18.

The primary outcome was the success rate of nonoperative management at 30 days and 1 year. To demonstrate an expected success rate of 85% required 35 patients in the nonoperative arm. Minneci reported the 30-day follow-up findings for the first 30 patients, and for 47 patients in the surgical group.

Demographic and clinical variables did not differ significantly between the groups. During the initial hospital stay, 28 of the 30 patients did not require appendectomy, resulting in a success rate of 93.3%. From discharge to 30 days, three more patients underwent appendectomy (including one who had a pathologically normal appendix), yielding a success rate of 89.3%.

The two treatment groups had similar rates of complications, fever, abdominal pain, nausea/vomiting, and emergency-department visits.

Length of stay averaged 38 hours in the nonoperative group and 20 hours in the appendectomy group (P<0.0001). Patients in the nonoperative group missed 3 days of school versus 5 in the surgical group (P=0.014) and resumed normal activities within 3 days as compared with 17 days in the surgical group (P<0.0001).

Parents/guardians resumed their normal schedules within 2 days compared with 3 days in the surgery group (NS).

Comparison of scores on the child quality-of life-questionnaire produced a significantly higher scores for the nonoperative protocol (P=0.011). Scores on the parent proxy questionnaire suggested an advantage for nonoperative care, but the difference did not reach statistical significance (P=0.061). Parent/guardian satisfaction was similar in the two groups.

Enrollment in the study is ongoing, said Minneci.

The presentation attracted considerable interest from the audience, beginning with session moderator Mark Mazziotti, MD, of Texas Children’s Hospital in Houston, who questioned the reasoning for withholding all feeding instead of using clear liquids.

“We didn’t know exactly what to expect from a safety standpoint, and we chose to err on the side of caution,” said Minneci. “We wanted them to get the antibiotics, and if they got worse, we wanted to get them to the operating room without having ingested anything by mouth.”

Mazziotti also asked about the approach to managing patients who returned with symptoms of appendicitis after discharge from the nonoperative protocol.

“Because we didn’t have exact information on the success rate and complications, any patient who returned with what might be appendicitis automatically went to surgery,” said Minneci. “In studies of adults, some patients have chosen to continue with nonoperative management, and they’ve done well, so it’s a reasonable option, but we did not entertain that option for our first study.”

Noting the one patient who had a normal appendix after surgery for recurrent symptoms, a Swedish physician said a similar phenomenon affected multiple patients in a similar study in which he had participated.

“Not every patient who has symptoms has appendicitis,” he said.