drugset / Trial / NCT03593252

Bowel Preparation in Elective Pediatric Colorectal Surgery

NCT03593252

RandomizedParallel-groupSingle-blindPrevention

Summary

Infections after elective intestinal surgery remain a significant burden for patients and for the health care system. The cost of treating a single surgical site infection is estimated at approximately $27,000. In adult patients, there is good evidence that the combination of oral antibiotics and mechanical bowel preparation is effective at reducing infections after intestinal surgery. In children, the body of evidence is much weaker. In this population, little evidence exists for oral antibiotics reducing infections and no data exists as to the effect of combining antibiotics with mechanical bowel preparation (such as polyethylene glycol (PEG)). The goal of the proposed study is to examine the effects of oral antibiotics with and without the combined use of mechanical bowel preparation on the rate of post-operative infectious complications in children aged 6 months to 18 years. This will be compared to the institution's current standard of care, which is to abstain from any type of mechanical bowel preparations or oral antibiotic administration before intestinal surgery.

Timeline

Start
2022-01-01
Primary completion
2024-01-30
Completion
2024-01-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Metronidazole Small molecule 15 mg/kg Oral
Subject Neomycin Unknown Oral
Subject Senna Traditional medicine (herbal / TCM)
Subject Sodium Picosulfate, Magnesium Oxide and Citric Acid Unknown
Background Cefazolin Small molecule 30 mg/kg Intravenous