NCT02174601

Brief Summary

After written consent for participating in clinical research studies, all clinical studies conducted to in the one day. The investigators will ask and record about bowel cleansing state in all patients who performed colonoscopy. There is no additional cost and the expected complications. Based on answer, the investigators will develop a prediction model for inadequate bowel preparation and prove validation. This model can take the additional measures to subjects predicting improper cleansing. It can contribute to improve the accuracy of the test and reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a improvement of the quality of management

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

June 23, 2014

Last Update Submit

September 5, 2016

Conditions

Keywords

bowel preparationcoolprepcolonoscopyprediction model

Outcome Measures

Primary Outcomes (1)

  • bowel cleansing state

    Based on quality of bowel preparation(bowel cleansing state), we will develop a prediction model for inadequate bowel preparation. And then, assess to efficiency and reducing subjects' satisfaction.

    average 24hours before colonoscopy after taking coolprep

Study Arms (1)

colonoscopy group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy subjects, more than 20 years old, who admitted to the health promotion center for performing colonoscopy.

You may qualify if:

  • Adults over 20 years old

You may not qualify if:

  • Less than 20 years old
  • Cardiac, renal, and metabolic dysfunction in patients with serious adverse
  • Mental or central nervous system disorders
  • Individuals with bwel obstruction
  • Individuals who can not read and understand the consent form (literacy, foreign, etc.) However, although individuals with vision / hearing disturbance and deterioration of cognitive abilities, they may participate in the research if can be able to complete the survey with one guardian or the help of researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance hospital

Seoul, Seoul, 120-752, South Korea

RECRUITING

Central Study Contacts

JAEJUN PARK, MD

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 25, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations