Bowel Preparation in Elective Pediatric Colorectal Surgery

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.

Conditions

• Colostomy
• Hirschsprung Disease - Pull Through
• Necrotizing Enterocolitis
• Inflammatory Bowel Diseases
• Meconium Ileus
• Bowel Obstruction
• Elective Surgery

Interventions

DRUG

Senna

Laxative,used for bowel preparation

DRUG

Sodium Picosulfate, Magnesium Oxide and Citric Acid

Laxative used for bowel preparation

DRUG

Metronidazole Oral

Oral antibiotic

DRUG

Neomycin

Oral non-absorbable antibiotic

DRUG

Cefazolin

Intravenous antibiotic to be given on anesthesia induction and prior to incision as a prophylactic antibiotic.

DRUG

Metronidazole

Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.

OTHER

Nil per os

Fasting orders according to anesthesia prior to surgery: No solid for \>=8 hours, no formula milk/full liquids \>= 4hours; no breast milk or clear fluids \>=2hours.

OTHER

Clear fluids the day before surgery

As part of bowel preparation, participants will be asked to stick to clear fluids following breakfast the day before surgery. Breast milk is allowed if applicable.

Sponsors & Collaborators

• McMaster Pediatric Surgery Rresearch Collaborative (MPSRC)

  collaborator UNKNOWN

• McMaster University

  lead OTHER

Principal Investigators

• Lisa VanHouwelingen, MD, MPH, FRCSC · McMaster Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2024-01-30

Completion

2024-01-30