External Validation of Models for Predicting Inadequate Bowel Preparation

June 27, 2021 updated by: Ningbo No. 1 Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315000
        • Ningbo First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing colonoscopy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
discrimination
Time Frame: cross-sectional analyses in 2020
Compare the area under the curve (AUC) between predictive models and acutal bowel preparation.
cross-sectional analyses in 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo No. 1 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

October 25, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 27, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IBPV-V1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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