ColostomyNCT03593252
Bowel Preparation in Elective Pediatric Colorectal Surgery
A study testing Senna, Sodium Picosulfate, Magnesium Oxide and Citric Acid and Metronidazole Oral in people with Colostomy and Hirschsprung Disease - Pull Through, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Colostomy, Hirschsprung Disease - Pull Through, Necrotizing Enterocolitis
- What is being tested?
- Senna, Sodium Picosulfate, Magnesium Oxide and Citric Acid and Metronidazole Oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Jan 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
Lisa VanHouwelingen, MD, MPH, FRCSC contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Colostomy, Hirschsprung Disease - Pull Through, Necrotizing Enterocolitis, Inflammatory Bowel Diseases, Meconium Ileus, Bowel Obstruction
- Being tested
- Senna, Sodium Picosulfate, Magnesium Oxide and Citric Acid, Metronidazole Oral, Neomycin, Cefazolin
- Medical subject headings
- Enterocolitis, Necrotizing, Inflammatory Bowel Diseases, Meconium Ileus, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SennaDrug
Also called Senokot
Laxative,used for bowel preparation
Sodium Picosulfate, Magnesium Oxide and Citric AcidDrug
Also called Pico-Salax
Laxative used for bowel preparation
Metronidazole OralDrug
Also called flagyl
Oral antibiotic
NeomycinDrug
Oral non-absorbable antibiotic
CefazolinDrug
Also called ancef
Intravenous antibiotic to be given on anesthesia induction and prior to incision as a prophylactic antibiotic.
MetronidazoleDrug
Also called Flagyl
Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.
Nil per osOther
Also called NPO
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.
Clear fluids the day before surgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Drug: Cefazolin; Drug: Metronidazole; Other: Nil per os |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (no. enrolled)
recruitment rate (percentage of eligible patients enrolled and retained to the end of study).
Measured: From randomization to 30 days post-operatively
rate of post-randomization exclusions
Patients excluded after being randomized
Measured: From randomization to 30 days post-operatively
Protocol deviations
Number of protocol deviations
Measured: From randomization to 30 days post-operatively
Adverse events
Any expected and unexpected adverse event, with grade of adverse event
Measured: From randomization to 30 days post-operatively
Incomplete follow-up
Number missing follow-up appointments at 2 week mark
Measured: From randomization to 30 days post-operatively
Secondary outcomes (11)
Superficial Incisional surgical site infection (SSI)
Rate of SI-SSI (superficial or deep, number of patients who developed SSI per group/subgroup).
Measured: 30 days post-operatively.
Deep incisional surgical site infection (SSI)
Rate of DI-SSI (number of patients who developed SSI per group/subgroup).
Measured: 30 days post-operatively.
Organ space - Surgical site infection (SSI)
Rate of OS- SSI (number of patients who developed OS-SSI per group/subgroup).
Measured: 30 days post-operatively.
Anastomotic leak - Surgical site infection (SSI)
Rate of anastomotic leak (verified by a contrast study or intra-operatively) (number of patients who developed OS-SSI per group/subgroup).
Measured: 30 days post-operatively.
Length of hospital stay
Post-operative hospitalization on primary admission in days
Measured: 30 days post-operatively.
Time to full enteric feed.
Post-operative return to full feed/diet in days
Measured: 30 days post-operatively.
Re-admission
admission in post-operative period for a reason related to the surgery (yes/No)
Measured: 30 days post-operatively.
Re-operation
Yes/No. Note:operation indication is directly related to the surgery
Measured: 30 days post-operatively.
Electrolyte disturbance
significant changes in electrolytes (abnormal levels) (Yes/No)
Measured: On day of surgery
Electrolyte disturbance
If abnormal levels were detected, whether this was associate by clinical signs (Yes/No)
Measured: On day of surgery
Clostridium difficile infection
Occurrence of C. difficile infection post-operatively (Yes/No)
Measured: 30 days post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Jan 2022 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Pediatric Surgery Rresearch Collaborative (MPSRC)
- Responsible party
- Sponsor
- Investigators
- Lisa VanHouwelingen, MD, MPH, FRCSC, Principal investigator, McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593252
- Sponsor's protocol ID
- Bowel_prep_pediatric_sx
- Status last verified
- Nov 2021
- First submitted
- 22 May 2018
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20638534Guenaga 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.
PubMed 21901677Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4, 287-291.
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.
PubMed 24817514Rangel 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.
PubMed 25598122Serrurier 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.
PubMed 22244415Smith 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.
PubMed 15082963Koullouros 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.
PubMed 27778060Janssen 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.
PubMed 30343324Zwart 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.
PubMed 30219553Ares 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.
PubMed 28433362Billingham 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.
PubMed 23961782Harris 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.
PubMed 18929686Toh 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.
PubMed 30646234Nelson 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.
PubMed 16291339