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EGD-assisted Bowel Preparation for Colonoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563744
First Posted: March 27, 2012
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rockford Gastroenterology Associates
  Purpose
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.

Condition Intervention
Esophagoscopy Techniques Colonoscopy Procedure: EGD-assisted administration of colonoscopy prep Procedure: Control Group received standard prep by oral administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: EGD-assisted Bowel Preparation for Colonoscopy

Resource links provided by NLM:


Further study details as provided by Rockford Gastroenterology Associates:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Enrollment: 82
Study Start Date: August 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563744


Locations
United States, Illinois
SwedishAmerican Hospital
Rockford, Illinois, United States, 61104
St. Anthony Medical Center
Rockford, Illinois, United States, 61108
Sponsors and Collaborators
Rockford Gastroenterology Associates
Investigators
Principal Investigator: Robert L. Barclay, MD Rockford Gastroenterology Associates, University of Illinois College of Medicine, Rockford
  More Information

Responsible Party: Rockford Gastroenterology Associates
ClinicalTrials.gov Identifier: NCT01563744     History of Changes
Other Study ID Numbers: EGD-assisted 2012
First Submitted: March 23, 2012
First Posted: March 27, 2012
Last Update Posted: April 19, 2016
Last Verified: April 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rockford Gastroenterology Associates:
colonoscopy
bowel preparation
tolerability
EGD-assisted