The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy

Not Applicable

Completed

• Conditions: Colonic Diseases
• Interventions: Other: Clear liquids; Other: Low residue breakfast and lunch

• Registration Number: NCT01876576
• Lead Sponsor: Thomas Jefferson University

Brief Summary

This study will evaluate the expansion of dietary options from clear liquids the entire day to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with MoviPrep® and its effect on preparation quality for colonoscopy.

Detailed Description

This study will evaluate the expansion of dietary options from clear liquids the entire day to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with MoviPrep® and its effect on preparation quality for colonoscopy. MoviPrep® is a commercially available 2 liter bowel purgative for use before colonoscopy in adults 18 years of age or older that is comprised of polyethylene glycol-electrolyte solution (PEG-ELS) plus sodium sulfate, sodium ascorbate, and ascorbic acid.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2013-06
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Last Update Submitted: 2013-06-11
• Study First Posted: 2013-06-12
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Elective outpatients > 18 yrs undergoing colonoscopy

Exclusion Criteria

• Unable or unwilling to give informed consent
• Age < 18 years
• Pregnant
• Breast feeding
• Gastroparesis - established or suspected
• Pseudo-obstruction - established or suspected
• Severe constipation (< 1 BM a week)
• Bowel obstruction
• Colon resection
• Chronic nausea or vomiting
• Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
• PEG allergy
• Significant psychiatric illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clear liquids	Clear liquids	Clear liquids the day of bowel preparation up to 2.5 hrs before colonoscopy
low residue diet	Low residue breakfast and lunch	Low residue breakfast and lunch up to 1pm; clear liquids thereafter up to 2.5 hrs before colonoscopy

Primary Outcome Measures

Name	Time	Method
Efficacy - Overall bowel cleansing based on Boston Bowel Preparation Scale score BBPS score of 2-3 for each segment AND total score	1 day (At colonoscopy)

Secondary Outcome Measures

Name	Time	Method
Efficacy - Individual colon segment cleansing Successful cleansing defined as BBPS score of 2 - 3 for a segment	1 day (At colonoscopy)

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States