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Pre-operative mechanical bowel preparation and prophylactic oral antibiotics for pediatric patients undergoing
Daniel Briatico1,2, Helene Flageole1,2, Noora Al-Shahwani1,3
1McMaster Pediatric Surgery Research Collaborative, McMaster University, Hamilton, ON, Canada.
Insights
This study assesses the feasibility of a trial on pre-operative bowel preparation for pediatric colorectal surgery. It explores oral antibiotics and mechanical bowel prep to reduce surgical site infections in children.
Area of Science:
- Pediatric Surgery
- Infectious Diseases
- Clinical Trial Design
Background:
- Post-operative infections are a significant concern in pediatric colorectal surgery.
- Evidence for pre-operative bowel preparation in children is limited compared to adults.
- The effectiveness of combined oral antibiotics and mechanical bowel preparation in pediatric patients is uncertain.
Purpose of the Study:
- To determine the feasibility of a randomized controlled trial (RCT) for pre-operative bowel preparation in pediatric colorectal surgery.
- To assess the efficacy of oral antibiotics, with or without mechanical bowel preparation, in reducing post-operative infections.
- To inform the design of a larger, multi-center trial.
Main Methods:
- A feasibility RCT involving participants aged 3 months to 18 years undergoing elective colorectal surgery.
- Participants randomized into three arms: oral antibiotics, oral antibiotics plus mechanical bowel preparation, or standard care.
- Feasibility outcomes include recruitment rates, protocol adherence, and adverse events; secondary outcomes assess infection rates and complications.
Main Results:
- This section is not applicable as the abstract describes a feasibility study and does not present results.
Conclusions:
- Successful completion of this feasibility trial will enable a larger, multi-center study.
- The findings will guide the evaluation of optimal pre-operative bowel preparation strategies for pediatric colorectal surgery.
Background:
Infections after elective colorectal surgery remain a significant burden for patients and the healthcare system. Adult studies suggest that the combination of oral antibiotics and mechanical bowel preparation is effective at reducing infections after colorectal surgery. In children, there is limited evidence for either of these practices and the utility of combining oral antibiotics with mechanical bowel preparation remains uncertain.
Methods:
This study aims to determine the feasibility of conducting a randomized controlled trial assessing the efficacy of oral antibiotics, with or without mechanical bowel preparation, in reducing the rates of post-operative infection in pediatric colorectal surgery. Participants aged 3 months to 18 years undergoing elective colorectal surgery will be randomized pre-operatively to one of three trial arms: (1) oral antibiotics; (2) oral antibiotics and mechanical bowel preparation; or (3) standard care. Twelve patients will be included in each trial arm. Feasibility outcomes of interest include the rate of participant recruitment, post-randomization exclusions, protocol deviations, adverse events, and missed follow-up appointments. Secondary outcomes include the rate of post-operative surgical site infections, length of hospital stay, time to full enteral feeds, reoperation, readmission, and complications.
Discussion:
If the results of this trial prove feasible, a multi-center trial will be completed with sufficient power to evaluate the optimal pre-operative bowel preperation for pediatric patients undergoing elective colorectal surgery.
Trial Registration:
ClinicalTrials.gov: NCT03593252.
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