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Is colostomy closure without mechanical bowel preparation safe in pediatric patients? A randomized clinical trial
Emilio Fernandez-Portilla1, Roberto Davila-Perez1, Jaime Nieto-Zermeño1
1Pediatric Surgery Department, Hospital Infantil de Mexico Federico Gomez, Doctor Márquez 162, Mexico City, Cuauhtémoc 06720, Mexico.
Insights
Withholding mechanical bowel preparation (MBP) before pediatric colostomy closure is safe and effective. Omitting MBP reduces patient discomfort and hospital stay, offering a potentially better approach for children undergoing colostomy takedown.
Area of Science:
- Pediatric Surgery
- Gastrointestinal Surgery
- Clinical Trials
Background:
- Mechanical bowel preparation (MBP) is commonly used before pediatric colostomy closure, despite questionable benefits and potential adverse effects.
- Evidence suggests MBP's utility in this procedure is not well-established.
- This study aimed to evaluate the necessity of MBP in pediatric colostomy takedown.
Purpose of the Study:
- To determine if withholding mechanical bowel preparation (MBP) increases complications during pediatric colostomy closure.
- To compare the safety and efficacy of colostomy takedown with and without MBP in children.
- To assess surgical site infections (SSI) and anastomotic leakage rates.
Main Methods:
- A randomized noninferiority clinical trial involving 79 pediatric patients was conducted.
- The experimental group did not receive MBP prior to colostomy closure.
- Safety outcomes were analyzed using appropriate statistical tests (chi-squared, t-test, Mann-Whitney U).
Main Results:
- No significant difference in superficial or deep surgical site infections (SSI) between groups.
- Equivalence in reoperation rates and no instances of anastomotic leakage in either group.
- Patients not receiving MBP experienced similar outcomes and shorter hospital stays, with no increased discomfort.
Conclusions:
- Withholding mechanical bowel preparation (MBP) prior to pediatric colostomy takedown is not associated with increased complications.
- Omitting MBP leads to improved patient comfort and reduced hospital length of stay.
- Colostomy closure without MBP is a safer and more effective procedure for children.
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.
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