Triple versus antibiotic monotherapy for complicated appendicitis: open clinical trial, Instituto Hondureño de Seguridad Social, Tegucigalpa.

Abstract

Background: In Honduras there is no published evidence on the eficacy of different antibiotic regimens for post-surgical management of acute complicated appendicitis in children. Objective: To determine eficacy and safety of triple versus antibiotic monotherapy in pediatric patients with acute complicated appendicitis, Hospital de Especialidades, Instituto Hondureño de Seguridad Social (IHSS), Tegucigalpa, 2011-2013. Methods: Open clinical trial, two therapeutic schemes: Triple Therapy (Ampicillin+Amikacin+ Clindamicina, GroupTT) and Ertapenem (GroupE) for 7 days. Patients diagnosed with complicated acute appendicitis and subjected to open appendectomy were included. Patients were evaluated at the outpatient clinic, 7 days after surgery. Approval was obtained by the IHSS Research Ethics Committee. Chi-square test, Relative Risk, 95% conidence interval, and p<0.05 value were used to determine differences between groups. Results: 58 patients were included in GrupoTT and 29 in GrupoE, average age was 7.3 years (IC95% 6.7-7.9) GroupTT and 8 years (IC95% 7-9) GrupoE. The average evolution of the clinical picture was 31.6 hours GroupTT and 43.8 hours GroupE (p=0.034). No signiicant differences were found regarding adverse effects of clinical signiicance, postoperative complications, intrahospital stay in days, or need for recourse/post-discharge complication readmission. Discussion: Monotherapy with ertapenem was similarly effective and safe as triple ampicillin+Amikacin+Clindamicin therapy currently used in the treatment of the paediatric patient with complicated appendicitis. The study is limited because the two study groups were different in the evolution of the disease.