NCT02317731

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

December 11, 2014

Last Update Submit

April 15, 2016

Conditions

Colon Cancer

Keywords

bowel preparation

Outcome Measures

Primary Outcomes (1)

  • Bowel preparation quality

    Bowel preparation quality will be measured using a validated scoring system (Boston Bowel Preparation Score) for bowel preparation

    1 day

Secondary Outcomes (1)

  • 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

    1 day

Study Arms (2)

Routine

NO INTERVENTION

Subjects will ingest the bowel preparation from a cup

Straw

EXPERIMENTAL

Subjects will ingest the bowel preparation with a straw

Other: Straw

Interventions

StrawOTHER

Bowel preparation ingestion with a straw

Straw

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Digestive Diseases, Temple Medical Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Louis A Chaptini, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 16, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

US(1)