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

NCT ID: NCT01452737

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Colonoscopy

Keywords

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colonoscopy bowel preparation Golytely

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2L Golytely/15mg bisacodyl

Subjects will be asked to take 2L Golytely + 15mg bisacodyl for bowel prep the day before colonoscopy.

Group Type EXPERIMENTAL

2L Golytely/bisacodyl

Intervention Type DRUG

Subjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure.

Standard bowel prep

Subject will receive standard bowel prep (4L Golytely) prior to colonoscopy.

Group Type ACTIVE_COMPARATOR

Standard Bowel Prep

Intervention Type DRUG

Subjects will be asked to take 4L of Golytely the day prior to procedure.

Interventions

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Standard Bowel Prep

Subjects will be asked to take 4L of Golytely the day prior to procedure.

Intervention Type DRUG

2L Golytely/bisacodyl

Subjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert A. Enns, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H11-02318

Identifier Type: -

Identifier Source: org_study_id