EGD-assisted Bowel Preparation for Colonoscopy

NCT ID: NCT01563744

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-03-31

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.

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.

Conditions

Esophagoscopy Techniques; Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

EGD-assisted administration of colonoscopy prep

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Control Group received standard prep by oral administration

Intervention Type: PROCEDURE

Control group receive standard oral colonoscopy prep.

Interventions

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.

Intervention Type: PROCEDURE

Control Group received standard prep by oral administration

Control group receive standard oral colonoscopy prep.

Intervention Type: PROCEDURE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockford Gastroenterology Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L. Barclay, MD

Role: PRINCIPAL_INVESTIGATOR

Rockford Gastroenterology Associates, University of Illinois College of Medicine, Rockford

Locations

SwedishAmerican Hospital

Rockford, Illinois, United States

St. Anthony Medical Center

Rockford, Illinois, United States

Countries

United States

Other Identifiers

EGD-assisted 2012

Identifier Type: -

Identifier Source: org_study_id