Clinical trial NCT01512394: Pre-op Bowel Prep Before Abdominal Surgery
Official title: Effects of Preoperative Bowel Preparation Prior to Elective Bowel Resection or Ostomy Closure in the Pediatric Patient Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pre-operative Bowel Prep
Keywords: bowel preparation
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of North Carolina
First posted: 2012-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: complications following surgery
timeFrame: 6 weeks
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 10 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References: