Effect of Use of Straw on Tolerability and Quality of Split Dose 4l-PEG Preparation

April 15, 2016 updated by: Yale University
The purpose of this study is to determine whether patients drinking their bowel preparation solution with a straw will have improved tolerability for ingestion of their bowel preparation solution and achieve a higher bowel preparation quality score than patients drinking their bowel preparation solution without a straw.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Section of Digestive Diseases, Temple Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 y/o scheduled for elective outpatient colonoscopy

Exclusion Criteria:

  • History of colonic surgery, Contra-indication for preparation (PEG solution), History of inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine
Subjects will ingest the bowel preparation from a cup
Experimental: Straw
Subjects will ingest the bowel preparation with a straw
Other: Straw
Bowel preparation ingestion with a straw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel preparation quality
Time Frame: 1 day
Bowel preparation quality will be measured using a validated scoring system (Boston Bowel Preparation Score) for bowel preparation
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability will be measured by subjective survey including a 5-point scale and a visual analog scale filled by the subjects the day of the colonoscopy
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Louis A Chaptini, MD, Yale School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (Estimate)

December 16, 2014

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1410014830

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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