Pre-op Bowel Prep Before Abdominal Surgery

Not Applicable

Withdrawn

• Conditions: Pre-operative Bowel Prep
• Interventions: Procedure: standard bowel prep; Procedure: no bowel prep

• Registration Number: NCT01512394
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-01-14
• Study First Posted: 2012-01-19
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard bowel prep	standard bowel prep	Standard bowel prep
No bowel prep	no bowel prep	No bowel prep

Primary Outcome Measures

Name	Time	Method
complications following surgery	6 weeks	compications such as infection, leaks, obstruction etc

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	10 days

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States