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Pre-op Bowel Prep Before Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01512394
Recruitment Status : Withdrawn (Study was never started.)
First Posted : January 19, 2012
Last Update Posted : January 28, 2016
University of North Carolina
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment Phase
Pre-operative Bowel Prep Procedure: standard bowel prep Procedure: no bowel prep Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Preoperative Bowel Preparation Prior to Elective Bowel Resection or Ostomy Closure in the Pediatric Patient Population
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arm Intervention/treatment
Active Comparator: Standard bowel prep
Standard bowel prep
Procedure: standard bowel prep
standard bowel prep

Experimental: No bowel prep
No bowel prep
Procedure: no bowel prep
no bowel prep

Primary Outcome Measures :
  1. complications following surgery [ Time Frame: 6 weeks ]
    compications such as infection, leaks, obstruction etc

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01512394

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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of North Carolina

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Responsible Party: Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas City Identifier: NCT01512394     History of Changes
Other Study ID Numbers: 11 09-139
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
bowel preparation