EGD-assisted Bowel Preparation for Colonoscopy

• ClinicalTrials.gov Identifier: NCT01563744
• Recruitment Status: Completed
• First Posted: March 27, 2012
• Last Update Posted: April 19, 2016
• Sponsor: Rockford Gastroenterology Associates
• Information provided by (Responsible Party): Rockford Gastroenterology Associates

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Esophagoscopy Techniques; Colonoscopy	Procedure: EGD-assisted administration of colonoscopy prep; Procedure: Control Group received standard prep by oral administration	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: EGD-assisted Bowel Preparation for Colonoscopy
• Study Start Date: August 2009
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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

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
• Other Study ID Numbers: EGD-assisted 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