EGD-assisted Bowel Preparation for Colonoscopy

April 15, 2016 updated by: Rockford Gastroenterology Associates
Adequate bowel preparation is of critical importance for colonoscopy. Particularly among hospitalized patients, inadequate bowel preparation for colonoscopy may arise due to patient intolerance to prescribed laxative regimen, elderly population, and co-existing conditions that impair the ability to ingest a large-volume laxative regimen. Improvements in bowel preparation for colonoscopy in hospitalized patients would likely improve patient care and reduce hospital costs. The purpose of this study is to determine if administering a portion of the bowel purgative via EGD could improve colonoscopy preparation in hospitalized patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this randomized controlled trial in hospitalized patients, patients in whom colonoscopy was anticipated the day following EGD were consented and randomized to either standard prep by mouth (split-dose PEG) or intervention group (instillation of the first 2 liters of Nulytely solution through the channel of the endoscope into the duodenal bulb, then continue standard prep). Data is collected on quality of prep and patient satisfaction in both groups.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Rockford, Illinois, United States, 61104
        • SwedishAmerican Hospital
      • Rockford, Illinois, United States, 61108
        • St. Anthony Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hospitalized patients
  • having EGD and expected to have colonoscopy the following day
  • written informed consent

Exclusion Criteria:

  • unable to tolerate EGD-assisted prep administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGD-assisted colonoscopy prep
2 liters of polyethylene glycol instilled through the channel of the endoscope during EGD when colonoscopy expected the following day. Patients follow a clear liquid diet, then ingest an addition 1 liter polyethylene glycol 4 hours prior to colonoscopy. Patients are also given a tap water enema 1 hour prior to colonoscopy.
Procedure: EGD-assisted administration of colonoscopy prep
Interventional group receive the first 2 liters of prep solution during EGD through the scope channel if colonoscopy expected the following day.
Active Comparator: Standard Colonoscopy Prep
Split-dose polyethylene glycol (2 liters pm prior to colonoscopy, 1 liter 4 hours prior to colonoscopy)), clear liquid diet, metoclopramide 10 mg IV 30 minutes prior to procedure, tap water enema 1 hr prior to colonoscopy
Procedure: Control Group received standard prep by oral administration
Control group receive standard oral colonoscopy prep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of bowel preparation
Time Frame: Twenty four to 48 hours - from time of consent prior to EGD until end of colonoscopy performed the following day
Quality of prep was assessed using the Ottawa bowel preparation scale (Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest endosc 2004;59:482-6)
Twenty four to 48 hours - from time of consent prior to EGD until end of colonoscopy performed the following day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient tolerance of bowel preparation
Time Frame: administered just prior to sedation for colonoscopy
Patients in both groups were asked to indicate if the bowel prep was easy, slightly difficult, moderately difficult, extremely difficult, or if they were unable to complete the prep as directed.
administered just prior to sedation for colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockford Gastroenterology Associates

Investigators

  • Principal Investigator: Robert L. Barclay, MD, Rockford Gastroenterology Associates, University of Illinois College of Medicine, Rockford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EGD-assisted 2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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