Bowel Preparation in Elective Pediatric Colorectal Surgery

November 25, 2021 updated by: McMaster University

Pre-Operative Mechanical Bowel Preparation And Prophylactic Oral Antibiotics For Pediatric Patients Undergoing Elective Colorectal Surgery: A Feasibility Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

A Cochrane review of randomized controlled trials of MBP use in adults showed no difference in the rate of wound infection or anastomotic leak in colon or rectal procedures with MBP compared to no preparation (Guenaga, Matos, & Wille-Jorgensen, 2011). Two recent systematic reviews and meta-analyses support those findings. Lok and colleagues (2018) identified two randomized controlled trials and four retrospective reviews for patient <21 years, looking at preoperative MBP and its effect on the incidence postoperative complications, including anastomotic leak, wound infection, and intra-abdominal infection (Janssen Lok M 2018). Overall, MBP before colorectal surgery did not significantly decrease the incidence of post-operative outcomes. This was consistent with findings from a systematic review in mechanical bowel preparation in pediatric population. The review showed that the risk of developing a post-operative infection was 10.1% in patients who received MBP compared to 9.1% in patients who did not receive MBP, resulting in no statistically significant difference difference (risk difference of -0.03% (95% CI, -0.09% - 0.03%)) (Zwart 2018).

With regards to OA alone, the adult literature showed promising results in favour of the OA. In a Cochrane review on antimicrobial prophylaxis in colorectal surgery, the addition of OA to the intravenous antibiotics was found to reduce surgical wound infection (RR 0.56, 95% CI 0.43 to 0.74) (Nelson, Gladman, & Barbateskovic, 2014).

There are fewer studies in the pediatric population on the subject, they contain fewer patients and are mainly retrospective in nature. In a multi-center retrospective study, Serrurier et al. (2012), reviewed outcomes in children who underwent colostomy closure, and found higher rates of wound infection (14% vs. 6%, p=0.04) and a longer hospital length of stay in children who received MBP. In a retrospective cohort study including 1581 pediatric patients from PHIS database, post-operative complications were found to be highest in the no preparation group compared to combination prep and OA alone (23.3%, 15.9%, and 14.2% respectively; p=0.002) (Ares 2018). One study compared MBP alone versus MBP with OA in children undergoing colostomy closure post anorectal malformation repair and found no difference in overall SSI rates (MBP+OA: 13% (7/53) versus MBP alone: 17% (7/12) p=0.64) (Breckler, Rescorla, & Billmire, 2010). The authors found that the use of MBP alone was associated with a greater risk of wound infection (14% vs. 6%, p=0.04) and a longer hospital stay. Evidence to support the sole use of oral antibiotics versus in combination with MBP is lacking, particularly in the pediatric literature, with more studies being required to address this question.

One recent meta-analysis including adults assessed 8458 adult patients (38 clinical trials), comparing 4 groups of different bowel preparation: MBP with OA, OA only, MBP only, and no preparation. The primary outcome was the total rate of incisional and organ/space SSIs. Results showed that only MBP with OA versus MBP alone was associated with a statistically significant reduction in SSI rates. The use of OA without MBP was not associated with a statistically significant reduction in SSI rates when compared to any other group. The authors concluded that MBP with OA was associated with the lowest risk of SSI, followed by OA only (Toh et al., 2018).

It remains unclear whether the addition of MBP to OA in pediatric population affects the rate of post-operative infectious complications positively or negatively. The current study is therefore needed to build on the work conducted in the adult literature to determine best practices for the pediatric population.

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 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 colon or rectal 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.

Study Type

Interventional

Enrollment (Anticipated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Pediatric patients aged three months to eighteen years being treated by the Pediatric General Surgery service at McMaster Children's Hospital.
  2. Undergoing elective colorectal surgery.
  3. Parents or legal guardian able to give free and informed consent.

Exclusion Criteria:

  1. Non-elective surgery

  2. Procedures that would not require mechanical bowel preparation:

    1. Colorectal resection with an existing diverting small bowel ostomy.
    2. Completion proctectomy - Ileal Pouch Anal Anasotmosis (IPAA)
    3. Closure of small bowel ostomy (e.g. ileostomy)
  3. Mechanical bowel obstruction
  4. Known hypersensitivity to laxatives or oral antibiotics (neomycin and metronidazole)
  5. Contraindication to oral antibiotics
  6. Patients on long-term antibiotics for other reasons
  7. Congestive heart failure
  8. Renal insufficiency
  9. Other medical conditions precluding the use of either oral antibiotics or mechanical bowel preparation
  10. Co-enrolment in another intervention trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination bowel prep

Patients will received mechanical bowel preparation (age appropriate dose, starting 2 days before surgery) and prophylactic oral antibiotics (3 doses, 1 day before surgery).

Clear fluids (or breast milk if applicable) will be given starting 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. The treating surgeon will rate the adequacy of the preparation intra-operatively.
Drug: Senna
Laxative,used for bowel preparation
Other Names:
  • Senokot
Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid
Laxative used for bowel preparation
Other Names:
  • Pico-Salax
Drug: Metronidazole Oral
Oral antibiotic
Other Names:
  • flagyl
Drug: Neomycin
Oral non-absorbable antibiotic
Drug: Cefazolin
Intravenous antibiotic to be given on anesthesia induction and prior to incision as a prophylactic antibiotic.
Other Names:
  • ancef
Drug: Metronidazole
Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.
Other Names:
  • Flagyl
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 Names:
  • NPO
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.
Active Comparator: Oral antibiotics
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).
Drug: Metronidazole Oral
Oral antibiotic
Other Names:
  • flagyl
Drug: Neomycin
Oral non-absorbable antibiotic
Drug: Cefazolin
Intravenous antibiotic to be given on anesthesia induction and prior to incision as a prophylactic antibiotic.
Other Names:
  • ancef
Drug: Metronidazole
Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.
Other Names:
  • Flagyl
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 Names:
  • NPO
Placebo Comparator: No prep
Patients will receive no pre-operative bowel prep. The will receive the standard care only.
Drug: Cefazolin
Intravenous antibiotic to be given on anesthesia induction and prior to incision as a prophylactic antibiotic.
Other Names:
  • ancef
Drug: Metronidazole
Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.
Other Names:
  • Flagyl
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 Names:
  • NPO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (no. enrolled)
Time Frame: From randomization to 30 days post-operatively
recruitment rate (percentage of eligible patients enrolled and retained to the end of study).
From randomization to 30 days post-operatively
rate of post-randomization exclusions
Time Frame: From randomization to 30 days post-operatively
Patients excluded after being randomized
From randomization to 30 days post-operatively
Protocol deviations
Time Frame: From randomization to 30 days post-operatively
Number of protocol deviations
From randomization to 30 days post-operatively
Adverse events
Time Frame: From randomization to 30 days post-operatively
Any expected and unexpected adverse event, with grade of adverse event
From randomization to 30 days post-operatively
Incomplete follow-up
Time Frame: From randomization to 30 days post-operatively
Number missing follow-up appointments at 2 week mark
From randomization to 30 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superficial Incisional surgical site infection (SSI)
Time Frame: 30 days post-operatively.
Rate of SI-SSI (superficial or deep, number of patients who developed SSI per group/subgroup).
30 days post-operatively.
Deep incisional surgical site infection (SSI)
Time Frame: 30 days post-operatively.
Rate of DI-SSI (number of patients who developed SSI per group/subgroup).
30 days post-operatively.
Organ space - Surgical site infection (SSI)
Time Frame: 30 days post-operatively.
Rate of OS- SSI (number of patients who developed OS-SSI per group/subgroup).
30 days post-operatively.
Anastomotic leak - Surgical site infection (SSI)
Time Frame: 30 days post-operatively.
Rate of anastomotic leak (verified by a contrast study or intra-operatively) (number of patients who developed OS-SSI per group/subgroup).
30 days post-operatively.
Length of hospital stay
Time Frame: 30 days post-operatively.
Post-operative hospitalization on primary admission in days
30 days post-operatively.
Time to full enteric feed.
Time Frame: 30 days post-operatively.
Post-operative return to full feed/diet in days
30 days post-operatively.
Re-admission
Time Frame: 30 days post-operatively.
admission in post-operative period for a reason related to the surgery (yes/No)
30 days post-operatively.
Re-operation
Time Frame: 30 days post-operatively.
Yes/No. Note:operation indication is directly related to the surgery
30 days post-operatively.
Electrolyte disturbance
Time Frame: On day of surgery
significant changes in electrolytes (abnormal levels) (Yes/No)
On day of surgery
Electrolyte disturbance
Time Frame: On day of surgery
If abnormal levels were detected, whether this was associate by clinical signs (Yes/No)
On day of surgery
Clostridium difficile infection
Time Frame: 30 days post-operatively.
Occurrence of C. difficile infection post-operatively (Yes/No)
30 days post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

McMaster Pediatric Surgery Rresearch Collaborative (MPSRC)

Investigators

  • Principal Investigator: Lisa VanHouwelingen, MD, MPH, FRCSC, McMaster Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 30, 2024

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bowel_prep_pediatric_sx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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