External Validation of Models for Predicting Inadequate B... | NCT04607161

Studies
External Validation of Models for Predicting Inadequate Bowel Preparation

NCT04607161

Sponsor

Ningbo No. 1 Hospital

Status

Completed

Last Update Posted

Jun 30, 2021Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Colonoscopy
Predictive Model
External Validation

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Oct 25, 2020

First Submission Date that Met QC Criteria

Oct 27, 2020

First Posted Date

Oct 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2021

Last Update Posted Date

Jun 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing colonoscopy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ningbo first hospital		Ningbo	Zhejiang	315000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35467123	Derived	Yuan X, Gao H, Liu C, Wang W, Xie J, Zhang Z, Xu L. External validation of two prediction models for adequate bowel preparation in Asia: a prospective study. Int J Colorectal Dis. 2022 Jun;37(6):1223-1229. doi: 10.1007/s00384-022-04156-0. Epub 2022 Apr 25.