Background: Mechanical bowel preparation (MBP) is largely used worldwide prior to colostomy closure in children, although its benefits are questioned by scientific evidence, and its use can cause adverse reactions. We hypothesized that colostomy closure procedures in children are not associated with increased complications (surgical site infection [SSI] and anastomotic leakage) when performed without MBP. Thus, we conducted a noninferiority trial to compare the safety and efficacy of colostomy takedown with and without MBP.
Methods: A randomized noninferiority clinical trial was conducted at Hospital Infantil de Mexico in Mexico City from 2015 to 2019, in which the experimental group did not receive MBP prior to colostomy closure. A total of 79 patients were analyzed, and the primary outcomes were safety-related. Data were analyzed using the chi-squared test, Student's t-test, or Mann-Whitney U test as appropriate.
Results: The demographics in both groups were comparable. Statistical analysis revealed equivalence in safety outcomes (superficial SSI, 22.5% vs 15.3% p = 0.420; deep SSI, 7.5% vs 0% p = 0.081; reoperation, p = 0.320; intestinal occlusion, p = 0.986); no anastomotic leakage was observed in any group. Secondary outcomes such as fasting time and length of hospital stay after surgery were also similar between the groups. However, patients who received MBP were admitted 2 days before surgery.
Conclusions: Our findings indicate that withholding MBP prior to colostomy takedowns in children is not associated with increased complications. Omitting MBP also leads to less discomfort and shortens hospital length of stay, suggesting that it has safer and more effective procedures.
Level of evidence: Randomized controlled clinical trial with adequate statistical power.
Keywords: Colostomy closure; Mechanical bowel preparation; Surgical site infections.
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