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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pre-operative Bowel Prep
• Intervention / Treatment: Procedure: standard bowel prep; Procedure: 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard bowel prep	Procedure: standard bowel prep; standard bowel prep
EXPERIMENTAL: No bowel prep	Procedure: no bowel prep; no bowel prep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications following surgery	compications such as infection, leaks, obstruction etc	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	10 days

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: University of North Carolina

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: January 14, 2012
• First Posted (ESTIMATE): January 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: bowel preparation
• Other Study ID Numbers: 11 09-139