Bowel Preparation in Elective Pediatric Colorectal Surgery

NCT03593252 | Unknown DMC

• 1 other identifier: Bowel_prep_pediatric_sx
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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 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

Outcome Measures

Primary Outcomes (5)

• Feasibility (no. enrolled)

  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

  Patients excluded after being randomized

  From randomization to 30 days post-operatively

• Protocol deviations

  Number of protocol deviations

  From randomization to 30 days post-operatively

• Adverse events

  Any expected and unexpected adverse event, with grade of adverse event

  From randomization to 30 days post-operatively

• Incomplete follow-up

  Number missing follow-up appointments at 2 week mark

  From randomization to 30 days post-operatively

Secondary Outcomes (11)

• 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.

Study Arms (3)

Combination bowel prep

EXPERIMENTAL

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; Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid; Drug: Metronidazole Oral; Drug: Neomycin; Drug: Cefazolin; Drug: Metronidazole; Other: Nil per os; Other: Clear fluids the day before surgery

Oral antibiotics

ACTIVE COMPARATOR

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; Drug: Neomycin; Drug: Cefazolin; Drug: Metronidazole; Other: Nil per os

No prep

PLACEBO COMPARATOR

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

Drug: Cefazolin; Drug: Metronidazole; Other: Nil per os

Interventions

Senna DRUG

Laxative,used for bowel preparation

Also known as: Senokot

Combination bowel prep

Sodium Picosulfate, Magnesium Oxide and Citric Acid DRUG

Laxative used for bowel preparation

Also known as: Pico-Salax

Combination bowel prep

Metronidazole Oral DRUG

Oral antibiotic

Also known as: flagyl

Combination bowel prep; Oral antibiotics

Neomycin DRUG

Oral non-absorbable antibiotic

Combination bowel prep; Oral antibiotics

Cefazolin DRUG

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

Also known as: ancef

Combination bowel prep; No prep; Oral antibiotics

Metronidazole DRUG

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

Also known as: Flagyl

Combination bowel prep; No prep; Oral antibiotics

Nil per os OTHER

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.

Also known as: NPO

Combination bowel prep; No prep; Oral antibiotics

Clear fluids the day before surgery OTHER

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.

Combination bowel prep

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Non-elective surgery
• Procedures that would not require mechanical bowel preparation:
• Colorectal resection with an existing diverting small bowel ostomy.
• Completion proctectomy - Ileal Pouch Anal Anasotmosis (IPAA)
• Closure of small bowel ostomy (e.g. ileostomy)
• Mechanical bowel obstruction
• Known hypersensitivity to laxatives or oral antibiotics (neomycin and metronidazole)
• Contraindication to oral antibiotics
• Patients on long-term antibiotics for other reasons
• Congestive heart failure
• Renal insufficiency
• Other medical conditions precluding the use of either oral antibiotics or mechanical bowel preparation
• Co-enrolment in another intervention trial

Sponsors & Collaborators

• McMaster University: lead
• McMaster Pediatric Surgery Rresearch Collaborative (MPSRC): collaborator

Related Publications (16)

• Breckler FD, Rescorla FJ, Billmire DF. Wound infection after colostomy closure for imperforate anus in children: utility of preoperative oral antibiotics. J Pediatr Surg. 2010 Jul;45(7):1509-13. doi: 10.1016/j.jpedsurg.2009.10.054.

  PMID: 20638534 BACKGROUND

• Guenaga KF, Matos D, Wille-Jorgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD001544. doi: 10.1002/14651858.CD001544.pub4.

  PMID: 21901677 BACKGROUND

• Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4, 287-291.

  BACKGROUND

• Nelson RL, Gladman E, Barbateskovic M. Antimicrobial prophylaxis for colorectal surgery. Cochrane Database Syst Rev. 2014 May 9;2014(5):CD001181. doi: 10.1002/14651858.CD001181.pub4.

  PMID: 24817514 BACKGROUND

• Rangel SJ, Islam S, St Peter SD, Goldin AB, Abdullah F, Downard CD, Saito JM, Blakely ML, Puligandla PS, Dasgupta R, Austin M, Chen LE, Renaud E, Arca MJ, Calkins CM. Prevention of infectious complications after elective colorectal surgery in children: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee comprehensive review. J Pediatr Surg. 2015 Jan;50(1):192-200. doi: 10.1016/j.jpedsurg.2014.11.028. Epub 2014 Nov 12.

  PMID: 25598122 BACKGROUND

• Serrurier K, Liu J, Breckler F, Khozeimeh N, Billmire D, Gingalewski C, Gollin G. A multicenter evaluation of the role of mechanical bowel preparation in pediatric colostomy takedown. J Pediatr Surg. 2012 Jan;47(1):190-3. doi: 10.1016/j.jpedsurg.2011.10.044.

  PMID: 22244415 BACKGROUND

• Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF. Wound infection after elective colorectal resection. Ann Surg. 2004 May;239(5):599-605; discussion 605-7. doi: 10.1097/01.sla.0000124292.21605.99.

  PMID: 15082963 BACKGROUND

• Koullouros M, Khan N, Aly EH. The role of oral antibiotics prophylaxis in prevention of surgical site infection in colorectal surgery. Int J Colorectal Dis. 2017 Jan;32(1):1-18. doi: 10.1007/s00384-016-2662-y. Epub 2016 Oct 24.

  PMID: 27778060 BACKGROUND

• Janssen Lok M, Miyake H, O'Connell JS, Seo S, Pierro A. The value of mechanical bowel preparation prior to pediatric colorectal surgery: a systematic review and meta-analysis. Pediatr Surg Int. 2018 Dec;34(12):1305-1320. doi: 10.1007/s00383-018-4345-y. Epub 2018 Oct 20.

  PMID: 30343324 BACKGROUND

• Zwart K, Van Ginkel DJ, Hulsker CCC, Witvliet MJ, Van Herwaarden-Lindeboom MYA. Does Mechanical Bowel Preparation Reduce the Risk of Developing Infectious Complications in Pediatric Colorectal Surgery? A Systematic Review and Meta-Analysis. J Pediatr. 2018 Dec;203:288-293.e1. doi: 10.1016/j.jpeds.2018.07.057. Epub 2018 Sep 12.

  PMID: 30219553 BACKGROUND

• Ares GJ, Helenowski I, Hunter CJ, Madonna M, Reynolds M, Lautz T. Effect of preadmission bowel preparation on outcomes of elective colorectal procedures in young children. J Pediatr Surg. 2018 Apr;53(4):704-707. doi: 10.1016/j.jpedsurg.2017.03.060. Epub 2017 Mar 30.

  PMID: 28433362 BACKGROUND

• Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

  PMID: 23961782 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Toh JWT, Phan K, Hitos K, Pathma-Nathan N, El-Khoury T, Richardson AJ, Morgan G, Engel A, Ctercteko G. Association of Mechanical Bowel Preparation and Oral Antibiotics Before Elective Colorectal Surgery With Surgical Site Infection: A Network Meta-analysis. JAMA Netw Open. 2018 Oct 5;1(6):e183226. doi: 10.1001/jamanetworkopen.2018.3226.

  PMID: 30646234 BACKGROUND

• Nelson RM, Ross LF. In defense of a single standard of research risk for all children. J Pediatr. 2005 Nov;147(5):565-6. doi: 10.1016/j.jpeds.2005.08.051. No abstract available.

  PMID: 16291339 BACKGROUND

• Briatico D, Flageole H, Al-Shahwani N, Farrokhyar F, VanHouwelingen L. Pre-operative mechanical bowel preparation and prophylactic oral antibiotics for pediatric patients undergoing elective colorectal surgery: a protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2024 May 25;10(1):85. doi: 10.1186/s40814-024-01476-6.

  PMID: 38796500 DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Inflammatory Bowel Diseases; Meconium Ileus; Intestinal Obstruction

Interventions

Sennosides; picosulfate sodium; Magnesium Oxide; Citric Acid; Pico-Salax; Metronidazole; Neomycin; Cefazolin

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoglycosides; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lisa VanHouwelingen, MD, MPH, FRCSC

  McMaster Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Briatico, MSc

CONTACT

905-521-2100; briaticd@mcmaster.ca

Lisa VanHouwelingen, MD, MPH, FRCSC

CONTACT

vanhoul@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patient's records will mention he/she is part of a study and will mention the study number, while the actual medications received (group allocation) will not be mentioned. The outcome detector, assessing the patient from day 1 in the hospital to the end of the study, will not have access to information on the study group allocation. The statistician analyzing the data will have a coded and de-identified version, and will be blinded to study groups to ensure unbiased analysis. For the purpose of blinding the data analyst, data on bowel prep diary will be withheld until analysis for all other outcomes is done and finalized. The principle investigators and the research coordinator will be involved in prescribing the prep regimen preoperatively and will not be blinded. The patient and family will be aware of the medications used and will not be blinded either. Also, the pharmacist will have access to the treatment allocation list, and cannot be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to the following study arms: 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): * 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.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: July 20, 2018
• Study Start: January 1, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share