Efficacy and safety of an abbreviated perioperative care bundle versus standard perioperative care in children undergoing elective bowel anastomoses: A randomized, noninferiority trial

Abstract

PurposeThe aim was to evaluate if an abbreviated perioperative care bundle (APCB) is noninferior to the standard care, in terms of efficacy and safety, in pediatric patients undergoing bowel anastomoses. MethodsA randomized, open, noninferiority trial with two parallel groups of equal size was carried out at the National Institute of Pediatrics in Mexico City, Mexico, from April 2016 to July 2018. The total number analyzed was 74 (37 per group).The APCB comprised same day admission, avoidance of mechanical bowel preparation, optimized antibiotic prophylaxis, and early feeding. Statistical analysis was done with Fisher's exact test or Chi2, and Student's T test. ResultsNo significant differences were found for demographic variables and type of disease, either for the safety (anastomotic leakage, p 0.753; organ/space surgical site infection, p 0.500) or for some efficacy outcomes (ileus or bowel obstruction, p 0.693). Other efficacy outcomes were better in the study group, with shorter median times for feeding tolerance (19 h vs. 92 h, p < 0.001), for first bowel movement (15 h vs. 36 h, p < 0.001), and for discharge (1 vs. 6 days, p < 0.001). ConclusionThe abbreviated care bundle was proven to be as safe but more efficacious than the standard care. Level of evidenceI — randomized controlled trial with adequate statistical power.