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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03593252 |
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Date of registration:
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22/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Bowel Preparation in Elective Pediatric Intestinal Surgery
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Scientific title:
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Mechanical Bowel Prep and Prophylactic Oral Antibiotic Use in Children: Implications for Intestinal Surgery Complications |
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Date of first enrolment:
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September 1, 2018 |
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Target sample size:
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48 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03593252 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Contacts
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Name:
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Tessa Elliott, BHsc, MSc |
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Address:
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Telephone:
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905-521-2100 |
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Email:
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elliot1@mcmaster.ca |
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Affiliation:
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Name:
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Helene Flageole, MD, MSc, FRCSC, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster Children's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Months
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Jejunostomy Stoma
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Ileostomy - Stoma
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NEC
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Bowel Obstruction
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Colostomy Stoma
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Hirschprung's Disease
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Meconium Ileus
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Inflammatory Bowel Diseases
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Intervention(s)
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Drug: Erythromycin
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Drug: Senna
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Drug: Metronidazole
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Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid
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Drug: Cefazolin
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Drug: Kanamycin
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Other: Nil per os
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Primary Outcome(s)
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Feasibility
[Time Frame: 30 days post-operatively]
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Secondary Outcome(s)
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anastomotic leak - Surgical site infection (SSI)
[Time Frame: 30 days post-operatively.]
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Length of hospital stay
[Time Frame: 30 days post-operatively.]
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Time to full enteric feed.
[Time Frame: 30 days post-operatively.]
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Re-admission
[Time Frame: 30 days post-operatively.]
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Clostridium difficile infection
[Time Frame: 30 days post-operatively.]
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electrolyte disturbance
[Time Frame: On day of surgery]
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Re-operation
[Time Frame: 30 days post-operatively.]
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superficial Incisional surgical site infection (SSI)
[Time Frame: 30 days post-operatively.]
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Organ space - Surgical site infection (SSI)
[Time Frame: 30 days post-operatively.]
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Deep incisional surgical site infection (SSI)
[Time Frame: 30 days post-operatively.]
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Secondary ID(s)
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Bowel_prep_pediatric_sx
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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