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NCT04607161 Clinical Trial

External Validation of Models for Predicting Inadequate Bowel Preparation

Colonoscopy Clinical Trial

Official title:
External Validation of Two Prediction Models for Adequate Bowel Preparation in Asia: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04607161
Other study ID # IBPV-V1.0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date December 31, 2020

Study information
Verified date June 2021
Source Ningbo No. 1 Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In order to obtain the risk level of patients with intestinal insufficiency through simple indicators, many foreign scholars have studied and developed their own prediction models. However, the current guideline indicates that there is insufficient evidence to recommend the use of a specialized predictive model for clinical practice.There are few studies on external validation of existing prediction models.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date December 31, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients undergoing colonoscopy. - patients older than 18 years. Exclusion Criteria: - Emergency colonoscopy. - Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv. - Pregnant or breastfeeding. - No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives < 90% of prescribed dose). - Refuse to sign informed consent. - The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation. - Temporarily change to colonoscopy for other reasons. - Incomplete colonoscopy due to insufficient parenteral preparation. - Lack of complete data.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
China Ningbo first hospital Ningbo Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary discrimination Compare the area under the curve (AUC) between predictive models and acutal bowel preparation. cross-sectional analyses in 2020
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