Comparing 4L Golytely to 2L Golytely With 15mg Bisacodyl Regimens for Inpatient Colonic Preparation

Not Applicable

Withdrawn

• Conditions: Colonoscopy
• Interventions: Drug: 2L Golytely/bisacodyl; Drug: Standard Bowel Prep

• Registration Number: NCT01452737
• Lead Sponsor: University of British Columbia

Brief Summary

The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-17
• Study Start: 2011-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Inpatients undergoing colonoscopy
• Age 19 or over

Exclusion Criteria

• Unable to provide informed consent
• Patients with constipation
• Patients with suspected bowel obstruction or severe inflammatory bowel disease
• Same-day colonoscopy
• Intensive/critical care patient
• History of colorectal resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2L Golytely/15mg bisacodyl	2L Golytely/bisacodyl	Subjects will be asked to take 2L Golytely + 15mg bisacodyl for bowel prep the day before colonoscopy.
Standard bowel prep	Standard Bowel Prep	Subject will receive standard bowel prep (4L Golytely) prior to colonoscopy.

Primary Outcome Measures

Name	Time	Method
Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups	30min	These are established rating scales to evaluate the quality of bowel prep. The ratings will be compared between the two groups.

Secondary Outcome Measures

Name	Time	Method
Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.	20hours	Participants will be asked to rate their bowel prep experience (based on ease of use) on a Likert scale. The number of participants in each level will subsequently be quantified (n, %) and compared between the two groups.
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups	20hours	Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada