Same-day, Reduced Volume Bowel Preparation

Bowel Preparation Clinical Trial

Official title:

Evaluating the Effectiveness of a Same-day, Reduced Volume Polyethylene Glycol + Electrolyte Solution (PEG-ELS) Bowel Preparation for Afternoon Colonoscopies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01044394
• Other study ID #: H-28808
• Status: Withdrawn
• Phase: Phase 2
• First received: January 5, 2010
• Last updated: August 30, 2012
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We seek to evaluate whether a same day, reduced liquid volume (2liters) polyethylene glycol (PEG-ELS) bowel preparation can achieve adequate colon cleansing in patients scheduled for afternoon colonoscopies. The primary outcome will be adequacy of the bowel preparation. Secondary outcomes will include Boston Bowel Preparation Scale score, patient compliance with completing the preparation, tolerability of the preparation, willingness to repeat the preparation, side effects, duration of procedure (endoscope insertion and withdrawal times), and polyp detection.

Description:

The diagnostic accuracy of colonoscopy depends on the quality of the preparation. The adequacy of the preparation determines whether complete visualization of the mucosa and identification of pathologic lesions is achieved. For reasons that are not entirely clear, colonoscopies scheduled in the afternoon have been identified as a risk factor for having an inadequate preparation. Standard bowel preparation regimens at BMC include polyethylene glycol- electrolyte solutions (PEG-ELS) in full (four liters) and reduced (two liters) forms. These laxatives are typically administered either the evening prior to the colonoscopy or in "split dose" (a portion the evening before and a portion the morning of the colonoscopy). The percent of failed colonoscopies due to a fair/poor preparation in our endoscopy unit is 17-20%. Our trial seeks to establish the efficacy and safety of a reduced volume PEG-ELS laxative given on the day of the colonoscopy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking patients referred for colonoscopy.

Exclusion Criteria:

• Age < 18,

• Pregnancy,

• History of bowel resection,

• Allergy to PEG-ELS, and

• Inability to provide informed consent.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• polyethylene glycol (PEG-ELS) and bisacodyl tablets
2 liters of PEG-ELS and 10mg of bisacodyl tablets once the morning of the colonoscopy

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: adequacy of bowel preparation.		1 year	No
Secondary	Boston Bowel Preparation Scale scores, subject compliance, subject tolerability, adverse events, colonoscopy insertion & withdrawal time, number of repeat procedures needed due to inadequate bowel preparation, polyp detection, and adenoma detection.		1 year	No