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

Colonoscopy Clinical Trial

Official title:

2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01452737
• Other study ID #: H11-02318
• Status: Withdrawn
• Phase: N/A
• First received: October 12, 2011
• Last updated: September 17, 2013
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2013
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Standard Bowel Prep
Subjects will be asked to take 4L of Golytely the day prior to procedure.
• 2L Golytely/bisacodyl
Subjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups	These are established rating scales to evaluate the quality of bowel prep. The ratings will be compared between the two groups.	30min	No
Secondary	Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups	Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups	20hours	No
Secondary	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.	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.	20hours	No