NCT01635725

Brief Summary

The purpose of this investigation is validate a new bowel preparation scale and to compare it to existing bowel preparation scales.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

July 4, 2012

Last Update Submit

March 23, 2017

Conditions

ColonoscopyBowel CleanlinessBowel Rating Scale

Keywords

colonoscopybowel cleanlinessbowel rating scale

Outcome Measures

Primary Outcomes (1)

  • Correlation coefficient between the PA and physician ratings of bowel cleanliness

    The quality of the colon preparation will be graded based on the OPS, BBPS, an adequate/inadequate scale and our new CBPS. The correlation between the endoscopist's cleanliness rating and the physician assistant's cleanliness rating will be calculated using the appropriate statistical measures. These statistical measures were chosen before the study began by our statistical consultant.

    During a Colonoscopy (about 20 min)

Secondary Outcomes (1)

  • Correlation coefficient between the PA and physician ratings of total bowel fluid.

    During a Colonoscopy (about 20 min)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients already planning to have a colonoscopy in our office endoscopy suite.

You may qualify if:

  • All Patients undergoing a colonoscopy in our office endoscopy suite

You may not qualify if:

  • Patients younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Services

Downers Grove, Illinois, 60515, United States

Location

Related Publications (1)

  • Gerard DP, Foster DB, Raiser MW, Holden JL, Karrison TG. Validation of a new bowel preparation scale for measuring colon cleansing for colonoscopy: the chicago bowel preparation scale. Clin Transl Gastroenterol. 2013 Dec 5;4(12):e43. doi: 10.1038/ctg.2013.16.

    PMID: 24304940RESULT

Study Officials

  • David P Gerard, MD

    Gastroenterology Services, Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2012

First Posted

July 10, 2012

Study Start

July 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

US(1)