EGD-assisted Bowel Preparation for Colonoscopy

NCT01563744 | Completed

• 1 other identifier: EGD-assisted 2012
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophagoscopy Techniques; Colonoscopy

Keywords

colonoscopy; bowel preparation; tolerability; EGD-assisted

Outcome Measures

Primary Outcomes (1)

• Quality of bowel preparation

  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)

  Twenty four to 48 hours - from time of consent prior to EGD until end of colonoscopy performed the following day

Secondary Outcomes (1)

• Patient tolerance of bowel preparation

  administered just prior to sedation for colonoscopy

Study Arms (2)

EGD-assisted colonoscopy prep

EXPERIMENTAL

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

Standard Colonoscopy Prep

ACTIVE COMPARATOR

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

Interventions

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.

EGD-assisted colonoscopy prep

Control Group received standard prep by oral administration PROCEDURE

Control group receive standard oral colonoscopy prep.

Standard Colonoscopy Prep

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalized patients
• having EGD and expected to have colonoscopy the following day
• written informed consent

You may not qualify if:

• unable to tolerate EGD-assisted prep administration

Sponsors & Collaborators

• Rockford Gastroenterology Associates: lead

Study Sites (2)

SwedishAmerican Hospital

Rockford, Illinois, 61104, United States

Location

St. Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Study Officials

• Robert L. Barclay, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: August 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 19, 2016

Record last verified: 2012-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)