Efficacy and safety of an abbreviated perioperative care bundle versus standard perioperative care in children undergoing elective bowel anastomoses: A randomized, noninferiority trial
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In brief
In brief
Randomized noninferiority trial (n=74) comparing an abbreviated perioperative care bundle to standard care in children undergoing elective bowel anastomoses. The abbreviated protocol—featuring same-day admission, no mechanical bowel prep, optimized antibiotics, and early feeding—demonstrated equivalent safety with improved efficacy outcomes including faster feeding tolerance.
Written by the GCMD Library team from the article.
Purpose
The 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.
Methods
A 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.
Results
No 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