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Bowel Preparation in Elective Pediatric Intestinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593252
Recruitment Status : Unknown
Verified July 2018 by McMaster University.
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colostomy Stoma Ileostomy - Stoma Jejunostomy Stoma Hirschprung's Disease NEC Inflammatory Bowel Diseases Meconium Ileus Bowel Obstruction Drug: Senna Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid Drug: Erythromycin Drug: Kanamycin Drug: Cefazolin Drug: Metronidazole Other: Nil per os Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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.

  1. Combination bowel prep: Mechanical preparation and oral non-absorbable antibiotics + standard care.
  2. Oral antibiotics + standard care.
  3. 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.
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.
Primary Purpose: Prevention
Official Title: Mechanical Bowel Prep and Prophylactic Oral Antibiotic Use in Children: Implications for Intestinal Surgery Complications
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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). 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.
Drug: Senna
Laxative,used for bowel preparation
Other Name: Senokot

Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid
Laxative used for bowel preparation
Other Name: Pico-Salax

Drug: Erythromycin
Oral non-absorbable antibiotic
Other Name: Eryc

Drug: Kanamycin
Oral non-absorbable antibiotic
Other Name: Kantrex

Drug: Cefazolin
Intravenous antibiotic to be given on anesthesia induction and prior to incision as a prophylactic antibiotic.
Other Name: ancef

Drug: Metronidazole
Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.
Other Name: 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 Name: NPO

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: Erythromycin
Oral non-absorbable antibiotic
Other Name: Eryc

Drug: Kanamycin
Oral non-absorbable antibiotic
Other Name: Kantrex

Drug: Cefazolin
Intravenous antibiotic to be given on anesthesia induction and prior to incision as a prophylactic antibiotic.
Other Name: ancef

Drug: Metronidazole
Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.
Other Name: 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 Name: 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 Name: ancef

Drug: Metronidazole
Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.
Other Name: 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 Name: NPO




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 30 days post-operatively ]
    recruitment rate (percentage of eligible patients enrolled and retained to the end of study).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. Length of hospital stay [ Time Frame: 30 days post-operatively. ]
    Post-operative hospitalization on primary admission in days

  6. Time to full enteric feed. [ Time Frame: 30 days post-operatively. ]
    Post-operative return to full feed/diet in days

  7. Re-admission [ Time Frame: 30 days post-operatively. ]
    admission in post-operative period for a reason related to the surgery (yes/No)

  8. Re-operation [ Time Frame: 30 days post-operatively. ]
    Yes/No. Note:operation indication is directly related to the surgery

  9. electrolyte disturbance [ Time Frame: On day of surgery ]
    significant changes in electrolytes (abnormal levels) (Yes/No)

  10. electrolyte disturbance [ Time Frame: On day of surgery ]
    If abnormal levels were detected, whether this was associate by clinical signs (Yes/No)

  11. Clostridium difficile infection [ Time Frame: 30 days post-operatively. ]
    Occurrence of C. difficile infection post-operatively (Yes/No)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593252


Contacts
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Contact: Tessa Elliott, BHsc, MSc 905-521-2100 ext 76692 elliot1@mcmaster.ca
Contact: Helene Flageole, MD, MSc, FRCSC, FACS flageol@mcmaster.ca

Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Helene Flageole, MD, MSc, FRCSC, FACS McMaster Children's Hospital
Publications:
Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4, 287-291.

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03593252    
Other Study ID Numbers: Bowel_prep_pediatric_sx
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Obstruction
Meconium Ileus
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Metronidazole
Cefazolin
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Kanamycin
Picosulfate sodium
Magnesium Oxide
Citric Acid
Sodium Citrate
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents