EGD-assisted Bowel Preparation for Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockford Gastroenterology Associates
ClinicalTrials.gov Identifier:
NCT01563744
First received: March 23, 2012
Last updated: April 10, 2012
Last verified: April 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Control group receive standard colonoscopy prep. Interventional group receive the first 2 liters of prep solution during EGD through the scope channel if colonoscopy expected the following day.
No Intervention: 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: EGD-assisted administration of colonoscopy prep
Control group receive standard colonoscopy prep. Interventional group receive the first 2 liters of prep solution during EGD through the scope channel if colonoscopy expected the following day.

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rockford Gastroenterology Associates
ClinicalTrials.gov Identifier: NCT01563744     History of Changes
Other Study ID Numbers: EGD-assisted 2012
Study First Received: March 23, 2012
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014