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Clinical Trials/NCT01512394
NCT01512394
Withdrawn
Not Applicable

Effects of Preoperative Bowel Preparation Prior to Elective Bowel Resection or Ostomy Closure in the Pediatric Patient Population

Children's Mercy Hospital Kansas City1 site in 1 countryNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-operative Bowel Prep
Sponsor
Children's Mercy Hospital Kansas City
Locations
1
Primary Endpoint
complications following surgery
Status
Withdrawn
Last Updated
10 years ago

Overview

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.

Detailed Description

At CMH, our current approach to preoperative management for elective intestinal surgery is not standardized amongst our Pediatric Surgical attendings. There are seven different attendings, each of whom individually dictates if a patient is to undergo a preoperative bowel prep, and if so, which bowel prep will be used. This is no different than the majority of practices across the US, including adult and pediatric patient populations. The aim of this study, therefore, is to standardize our current management and assess if the presence or absence of a preoperative bowel prep has an effect on post-operative outcomes. The goal is to evaluate the effect of the bowel preparation not the surgical procedure itself.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Responsible Party
Principal Investigator
Principal Investigator

Shawn St. Peter

Associate Professor

Children's Mercy Hospital Kansas City

Eligibility Criteria

Inclusion Criteria

  • All children, ages 3 months to 17 years, who will undergo an elective bowel resection or ostomy closure at CMH

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

complications following surgery

Time Frame: 6 weeks

compications such as infection, leaks, obstruction etc

Secondary Outcomes

  • Length of hospital stay(10 days)

Study Sites (1)

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