EGD-assisted Bowel Preparation for Colonoscopy

Colonoscopy Clinical Trial

Official title:

EGD-assisted Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563744
• Other study ID #: EGD-assisted 2012
• Status: Completed
• Phase: N/A
• First received: March 23, 2012
• Last updated: April 15, 2016
• Start date: August 2009
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Rockford Gastroenterology Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy
• Esophagoscopy Techniques

Intervention

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.
• Control Group received standard prep by oral administration
Control group receive standard oral colonoscopy prep.

Locations

Country	Name	City	State
United States	St. Anthony Medical Center	Rockford	Illinois
United States	SwedishAmerican Hospital	Rockford	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rockford Gastroenterology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient tolerance of bowel preparation	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.	administered just prior to sedation for colonoscopy	No