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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03945890
Other study ID # 104107-E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 12, 2015
Est. completion date October 30, 2017

Study information

Verified date May 2019
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Importing quality improvement practices and enhances health education to improving quality of bowel preparation for health screening colonoscopy

This is a retrospective data analysis study aimed at obtaining the types of purgative treatments used, the results of bowel preparation, and each subject's demographic characteristics (Age & Gender).


Description:

This study aimed to check-up the result and the impact of patient education using a medical team resource management (TRM) method on the adequacy of bowel preparation.

Investigators collected a total of 2,104 (884 female, 1,220 male) healthy subjects who underwent a health check-up colonoscopy screening were enrolled before and after the application of the TRM program intervention. The efficacy of the TRM intervention and the factors affecting bowel preparation were estimated using multivariate logistic regression in this study.

Enrollment of study subjects and data collection: The subjects enrolled in this study were those who received a health check-up colonoscopy screening in a tertiary center, Far Eastern Memorial Hospital (FEMH), in Taiwan from March 2013 to August 2014. A total of 2,104 healthy subjects who underwent check-up colonoscopy screening were enrolled during the pre-intervention, post-intervention, and validation periods. Investigators need to collect each subject's demographic characteristics (Age & Gender) and the types of purgative treatments used were collected to analyze. According to the Aronchick Bowel Preparation Scale, this study divided the degree of bowel cleansing into four levels, namely, "Excellent", "Good", "Fair" and "Poor". Investigators also need to collect the results of bowel preparation to calculate of the adequate bowel cleansing rate was defined further as the percentage of the participants with "Excellent" or "Good" cleansing in our analysis.


Recruitment information / eligibility

Status Completed
Enrollment 2104
Est. completion date October 30, 2017
Est. primary completion date February 28, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- The healthy population who received a health check-up colonoscopy screening in Far Eastern Memorial Hospital (FEMH)

- Exam date from March 2013 to August 2014

- Age from 20 y/o to 80 y/o

Exclusion Criteria:

- Gastroenterology outpatients/inpatients

- Missing data subjects

- Out of the Age limits subjects

- Out of the Time period subjects

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Oriental Institute of Technology / Far Eastern Memorial Hospital New Taipei City Pan-Chiao Dist.

Sponsors (2)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The well-designed education intervention can improve the rate of adequate bowel pr eparation for health screening colonoscopy. The multivariate logistic regression analysis results for adequate bowel preparation after adjustments for age, gender, purgative type, to analyze the adequate bowel preparation rate with different intervention period.
Bowel preparation rate were the Good & Excellent % of the total cases. Each subject's demographic characteristics (Age & Gender), the type of purgative and bowel preparation rate were collected from Far Eastern Memorial Hospital (FEMH) in Taiwan. This study was secondary data analysis, and the data contains no person's details, images, or videos. This is a retrospective data analysis study, investigators collected data enrolled in this study were those who received a health check-up colonoscopy screening.
From March 2013 to August 2014.
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