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Completed

NCT Number: NCT01563744

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Anthony Medical Center, Rockford, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EGD-assisted administration of colonoscopy prep

Procedure

Interventional group receive the first 2 liters of prep solution during EGD through the scope channel if colonoscopy expected the following day.

Control Group received standard prep by oral administration

Procedure

Control group receive standard oral colonoscopy prep.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rockford Gastroenterology Associates

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2012
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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