Pre-op Bowel Prep Before Abdominal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Collaborator:
University of North Carolina
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01512394
First received: December 13, 2011
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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 Intervention
Pre-operative Bowel Prep
Procedure: standard bowel prep
Procedure: no bowel prep

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • complications following surgery [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    compications such as infection, leaks, obstruction etc


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512394

Contacts
Contact: Shawn D St. Peter, MD 816 983-6479 sspeter@cmh.edu
Contact: Susan W Sharp, PhD 816-983-6670 swsharp@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn D St. Peter, MD    816-983-6479    sspeter@cmh.edu   
Contact: Susan W Sharp, PhD    816-983-6670    swsharp@cmh.edu   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of North Carolina
  More Information

No publications provided

Responsible Party: Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01512394     History of Changes
Other Study ID Numbers: 11 09-139
Study First Received: December 13, 2011
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
bowel preparation

ClinicalTrials.gov processed this record on August 19, 2014