Study Stopped
Study was never started.
Pre-op Bowel Prep Before Abdominal Surgery
Effects of Preoperative Bowel Preparation Prior to Elective Bowel Resection or Ostomy Closure in the Pediatric Patient Population
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Current management of elective bowel surgery typically involves performing a preoperative bowel preparation ("bowel prep") in many instances; however, this practice is not standardized at most institutions. Over the years, bowel preps have been used in an attempt to decrease the risk of complications associated with gastrointestinal surgery. However, there is limited adequate data to support this clinical management in the pediatric patient population. The investigator plans to perform a prospective, randomized study of our pediatric surgical patients who will undergo an elective bowel resection or ostomy closure to assess if a bowel prep prior to surgical intervention affects their postoperative course. The aim of this study is to evaluate for differences that may alter and improve future management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 28, 2016
January 1, 2016
2.1 years
December 13, 2011
January 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complications following surgery
compications such as infection, leaks, obstruction etc
6 weeks
Secondary Outcomes (1)
Length of hospital stay
10 days
Study Arms (2)
Standard bowel prep
ACTIVE COMPARATORStandard bowel prep
No bowel prep
EXPERIMENTALNo bowel prep
Interventions
Eligibility Criteria
You may qualify if:
- All children, ages 3 months to 17 years, who will undergo an elective bowel resection or ostomy closure at CMH
You may not qualify if:
- Patients whose operation was performed emergently, and hence a bowel prep was not possible preoperatively;
- If they necessitate a diverting proximal ostomy;
- If they have any known intra-abdominal infection preoperatively;
- If an intra-operative colonoscopy is necessary, and hence the patient must have a preoperative bowel prep.
- No patients with an underlying malignancy or immunodeficiency or with renal, metabolic or cardiac conditions will be included.
- No patients with known allergies to any medication used in the bowel preparation will be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 13, 2011
First Posted
January 19, 2012
Study Start
November 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 28, 2016
Record last verified: 2016-01