A Predictive Model for Inadequate Bowel Preparation Befor... | NCT02726893

Studies
A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation

NCT02726893

Sponsor

Shandong University

Status

Completed

Last Update Posted

Mar 20, 2017Actual

Enrollment

1,504Actual

Phase

Not provided

Conditions

Bowel Cleansing Quality
Predictors
Colonoscopy
Boston Bowel Preparation Scale

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

Mar 2017

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

Apr 2016Actual

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Mar 25, 2016

First Submission Date that Met QC Criteria

Mar 29, 2016

First Posted Date

Apr 4, 2016Estimated

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

Mar 16, 2017

Last Update Posted Date

Mar 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

About 30% of patients were reported to suffer inadequate bowel preparation.

Detailed Description

Risk factors, such as diabetes, constipation, history of intra-abdominal or pelvic surgery, etc, have been demonstrated to be important predictors for inadequate bowel preparation. The aim of the study is to create and verify a predictive model for inadequate bowel preparation in Chinese.

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

1,504Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients undergoing colonoscopy		patients undergoing colonoscopy were observed in terms of the bowel preparation quality which is measured by Boston Bowel Preparation Scale (BBPS).	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other		patients undergoing colonoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score.	inadequate bowel preparation	5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing colonoscopy.
patients older than 18 years.

Exclusion Criteria:

patients referred for emergency colonoscopy.

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

patients undergoing colonoscopy.
patients older than 18 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Li Yanqing, PhD,MD	Qilu Hospital of Shandong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University		Jinan	Shandong	250012	China