Inflammatory Bowel Diseases Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 81 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
McMaster University | McMaster Pediatric Surgery Rresearch Collaborative (MPSRC) |
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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. — View Citation
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. Erratum in: J Pediatr Surg. 2010 Nov;45(11):2292. — View Citation
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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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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. Review. — View Citation
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. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility (no. enrolled) | recruitment rate (percentage of eligible patients enrolled and retained to the end of study). | From randomization to 30 days post-operatively | |
Primary | rate of post-randomization exclusions | Patients excluded after being randomized | From randomization to 30 days post-operatively | |
Primary | Protocol deviations | Number of protocol deviations | From randomization to 30 days post-operatively | |
Primary | Adverse events | Any expected and unexpected adverse event, with grade of adverse event | From randomization to 30 days post-operatively | |
Primary | Incomplete follow-up | Number missing follow-up appointments at 2 week mark | From randomization to 30 days post-operatively | |
Secondary | Superficial Incisional surgical site infection (SSI) | Rate of SI-SSI (superficial or deep, number of patients who developed SSI per group/subgroup). | 30 days post-operatively. | |
Secondary | Deep incisional surgical site infection (SSI) | Rate of DI-SSI (number of patients who developed SSI per group/subgroup). | 30 days post-operatively. | |
Secondary | Organ space - Surgical site infection (SSI) | Rate of OS- SSI (number of patients who developed OS-SSI per group/subgroup). | 30 days post-operatively. | |
Secondary | 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). | 30 days post-operatively. | |
Secondary | Length of hospital stay | Post-operative hospitalization on primary admission in days | 30 days post-operatively. | |
Secondary | Time to full enteric feed. | Post-operative return to full feed/diet in days | 30 days post-operatively. | |
Secondary | Re-admission | admission in post-operative period for a reason related to the surgery (yes/No) | 30 days post-operatively. | |
Secondary | Re-operation | Yes/No. Note:operation indication is directly related to the surgery | 30 days post-operatively. | |
Secondary | Electrolyte disturbance | significant changes in electrolytes (abnormal levels) (Yes/No) | On day of surgery | |
Secondary | Electrolyte disturbance | If abnormal levels were detected, whether this was associate by clinical signs (Yes/No) | On day of surgery | |
Secondary | Clostridium difficile infection | Occurrence of C. difficile infection post-operatively (Yes/No) | 30 days post-operatively. |
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