Same-day, Reduced Volume Bowel Preparation

NCT01044394 | Withdrawn Phase 2 DMC

• 1 other identifier: H-28808
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bowel Preparation

Keywords

colonoscopy; bowel preparation; polyethylene glycol; Quality in endoscopy; Bowel Preparation for colonoscopy

Outcome Measures

Primary Outcomes (1)

• Primary outcome: adequacy of bowel preparation.

  1 year

Secondary Outcomes (1)

• 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

Study Arms (1)

same day, reduced volume PEG-ELS prep

EXPERIMENTAL

Patients with colonoscopies scheduled in the afternoon will complete 2 liters of PEG-ELS solution the morning of their colonoscopy.

Drug: polyethylene glycol (PEG-ELS) and bisacodyl tablets

Interventions

polyethylene glycol (PEG-ELS) and bisacodyl tablets DRUG

2 liters of PEG-ELS and 10mg of bisacodyl tablets once the morning of the colonoscopy

same day, reduced volume PEG-ELS prep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking patients referred for colonoscopy.

You may not qualify if:

• Age \< 18,
• Pregnancy,
• History of bowel resection,
• Allergy to PEG-ELS, and
• Inability to provide informed consent.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Polyethylene Glycols; Bisacodyl

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Brian Jacobson, MD

  Boston Medicial Center Gastroenterology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of medicine

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

US (1)