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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
History of Changes

March 23, 2012
April 10, 2012
August 2009
March 2012   (final data collection date for primary outcome measure)
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)
Quality of bowel preparation [ Time Frame: during colonoscopy ] [ Designated as safety issue: No ]
Quality of perp 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)
Complete list of historical versions of study NCT01563744 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
EGD-assisted Bowel Preparation for Colonoscopy
EGD-assisted Bowel Preparation for Colonoscopy

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Esophagoscopy Techniques
  • 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.
  • 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.
    Intervention: Procedure: EGD-assisted administration of colonoscopy prep
  • 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
    Intervention: Procedure: EGD-assisted administration of colonoscopy prep
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01563744
EGD-assisted 2012
No
Rockford Gastroenterology Associates
Rockford Gastroenterology Associates
Not Provided
Principal Investigator: Robert L. Barclay, MD Rockford Gastroenterology Associates, University of Illinois College of Medicine, Rockford
Rockford Gastroenterology Associates
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP