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NCT02174601 Clinical Trial

A Pre-endoscopic Prediction Model for Inadequate Bowel Preparation in Patients Receiving Split Dose Polyethylene Glycol Preparation

Colonoscopy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02174601
Other study ID # 3-2013-0292
Secondary ID
Status Recruiting
Phase N/A
First received June 23, 2014
Last updated September 5, 2016
Start date April 2014
Est. completion date August 2017

Study information
Verified date September 2016
Source Yonsei University
Contact JAEJUN PARK, MD
Phone 82-2-2019-4371
Email JAEJPARK@yuhs.ac
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Adults over 20 years old

Exclusion Criteria:

- 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Gangnam Severance hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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