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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Colonoscopy
• External Validation
• Predictive Model

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