Pre-op Bowel Prep Before Abdominal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pre-operative Bowel Prep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard bowel prep

Group Type ACTIVE_COMPARATOR

standard bowel prep

Intervention Type PROCEDURE

standard bowel prep

No bowel prep

Group Type EXPERIMENTAL

no bowel prep

Intervention Type PROCEDURE

no bowel prep

Interventions

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standard bowel prep

Intervention Type PROCEDURE

no bowel prep

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No