Bowel Preparation in Elective Pediatric Intestinal Surgery

Mechanical Bowel Prep and Prophylactic Oral Antibiotic Use in Children: Implications for Intestinal Surgery Complications

Sponsors

Lead Sponsor: McMaster University

Source McMaster University
Brief 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 current practices, which is to abstain from any type of mechanical bowel preparations or oral antibiotic administration before intestinal surgery.

Detailed Description

Background: Colorectal surgery is associated with high rates of surgical site infections (SSI) in both children and adults, reported in excess of 25%, attracting great interest for patient care quality improvement. In a recent NSQIP-Pediatric database review, colorectal procedures accounted for 2.5% of the caseload and contributed 7.1% of the SSI burden, making this group of procedures an important target for SSI reduction. Some measures under investigation are mechanical bowel preparation (MBP) (oral or rectal) and oral non-absorbable antibiotics (OA) like neomycin, erythromycin and metronidazole. The former is thought to potentially decrease the stool load and decrease contamination during surgery, while the latter is thought to decrease SSI by decreasing the bacterial load in bowel. Nichols and Condon popularized bowel preparation in 1972 and 1973, after showing reduction of post-operative infectious complications with the use of MBP and OA. The regimen extended over three-days, requiring hospital admission, diet alteration (low residue / clear diet), oral and rectal MBP and OA. This has changed to a shorter prep, yet the regimen of OA (neomycin and erythromycin or metronidazole PO, 4 doses starting afternoon before surgery) is still cited as most commonly used in adult studies. The possibility of increase in colonic bacterial resistance moved surgeons away from OA, but recent adult studies have showed the contrary renewing interest in their use. The current adult literature shows clear benefit gained by the use of OA. This is less clear in the pediatric literature. Both adult and pediatric literature are lacking in the knowledge of benefit added by using MBP to OA. Our current practice, as is the case of multiple pediatric center, is to use NO bowel preparation in any pediatric intestinal procedure. Purpose: This is a pilot study to check the feasibility of conducting a randomized controlled trial to assess the efficacy of oral nonabsorbable antibiotics, with or without the use of mechanical bowel preparation, in reducing the rate of post-operative infectious complications occurring within 30 days post-operatively in children and adolescents (aged 6 months to 18 years) undergoing elective intestinal surgery. The investigator intend to study two subgroups: small bowel surgery and colorectal surgery. Post-operative complications include: surgical site infections (incisional, organ-space, and anatomic leak), length of hospital stay, readmission, post-operative use of therapeutic antibiotics, re-operation, occurrence of electrolyte disturbances (in case MBP was used), and occurrence of C. difficile infection.

Overall Status Unknown status
Start Date 2018-09-01
Completion Date 2020-12-31
Primary Completion Date 2020-08-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility 30 days post-operatively
Secondary Outcome
Measure Time Frame
superficial Incisional surgical site infection (SSI) 30 days post-operatively.
Deep incisional surgical site infection (SSI) 30 days post-operatively.
Organ space - Surgical site infection (SSI) 30 days post-operatively.
anastomotic leak - Surgical site infection (SSI) 30 days post-operatively.
Length of hospital stay 30 days post-operatively.
Time to full enteric feed. 30 days post-operatively.
Re-admission 30 days post-operatively.
Re-operation 30 days post-operatively.
electrolyte disturbance On day of surgery
electrolyte disturbance On day of surgery
Clostridium difficile infection 30 days post-operatively.
Enrollment 48
Condition
Intervention

Intervention Type: Drug

Intervention Name: Senna

Description: Laxative,used for bowel preparation

Arm Group Label: Combination bowel prep

Other Name: Senokot

Intervention Type: Drug

Intervention Name: Sodium Picosulfate, Magnesium Oxide and Citric Acid

Description: Laxative used for bowel preparation

Arm Group Label: Combination bowel prep

Other Name: Pico-Salax

Intervention Type: Drug

Intervention Name: Erythromycin

Description: Oral non-absorbable antibiotic

Other Name: Eryc

Intervention Type: Drug

Intervention Name: Kanamycin

Description: Oral non-absorbable antibiotic

Other Name: Kantrex

Intervention Type: Drug

Intervention Name: Cefazolin

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

Other Name: ancef

Intervention Type: Drug

Intervention Name: Metronidazole

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

Other Name: Flagyl

Intervention Type: Other

Intervention Name: Nil per os

Description: 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 Name: NPO

Eligibility

Criteria:

Inclusion Criteria: - Patients aged six months to eighteen years presenting to the Pediatric General Surgery service at McMaster Children's Hospital for elective colorectal surgery will be screened for inclusion in this study. Exclusion Criteria: - Mechanical bowel obstruction - Known hypersensitivity to laxatives or oral antibiotics - Congestive heart failure - Renal insufficiency - Other medical conditions precluding the use of either oral antibiotics or mechanical bowel preparations

Gender:

All

Minimum Age:

6 Months

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Helene Flageole, MD, MSc, FRCSC, FACS Principal Investigator McMaster Children's Hospital
Overall Contact

Last Name: Tessa Elliott, BHsc, MSc

Phone: 905-521-2100

Phone Ext.: 76692

Email: [email protected]

Verification Date

2018-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Combination bowel prep

Type: Experimental

Description: Patients will received mechanical bowel preparation (age appropriate dose, starting 2 days before surgery) and prophylactic oral antibiotics (3 doses, 1 day before surgery). The standard care will also be delivered (NPO for anesthesia and intravenous antibiotics on induction) Patients/parents will be provided with stool diary to document the adequacy of preparation. This will include frequency and character of stool according to Bristol grade.

Label: Oral antibiotics

Type: Active Comparator

Description: The patients will receive prophylactic oral antibiotics (3 doses, 1 day before surgery)as well as standard care (NPO for anesthesia and intravenous antibiotics on induction).

Label: No prep

Type: Placebo Comparator

Description: Patients will receive no pre-operative bowel prep. The will receive the standard care only.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Patients will be stratified into small bowel surgery and large bowel surgery, then randomized to the following study arms. Note: small bowel surgery do not require mechanical bowel preparation since the content is already fluid. So this subgroup will be randomized to groups 2 and 3 only. Combination bowel prep: Mechanical preparation and oral non-absorbable antibiotics + standard care. Oral antibiotics + standard care. No preparation, with standard care. Standard care (all groups): Standard nil per os (NPO) prior to general anesthesia Solids until 8 hours prior to surgery, formula until 6 hours, breast milk until 4 hours, clear fluids until 2 hours Prophylactic IV antibiotics Cefazolin (30mg/kg) and metronidazole (15mg/kg) within 60 minutes of incision Re-dosing if procedure exceeds 4 hours In case of beta-lactam allergy allergy, clindamycin 5mg/kg and gentamicin 7mg/kg will be used.

Primary Purpose: Prevention

Masking: Double (Care Provider, Outcomes Assessor)

Masking Description: While it is not infeasible to have all the study personnel blinded to which treatment arm the participants are in, nurses caring for participants while they are admitted to the hospital after surgery will not be aware which treatment the participant received. Also, outcome assessors (nurse practitioner or physician) will be masked to intervention.

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