Pre-op Bowel Prep Before Abdominal Surgery

Pre-operative Bowel Prep Clinical Trial

Official title:

Effects of Preoperative Bowel Preparation Prior to Elective Bowel Resection or Ostomy Closure in the Pediatric Patient Population

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01512394
• Other study ID #: 11 09-139
• Status: Withdrawn
• Phase: N/A
• First received: December 13, 2011
• Last updated: January 27, 2016
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-operative Bowel Prep

Intervention

Procedure:
• standard bowel prep
standard bowel prep
• no bowel prep
no bowel prep

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications following surgery	compications such as infection, leaks, obstruction etc	6 weeks	Yes
Secondary	Length of hospital stay		10 days	No