A Comparison of Bowel Preparation for Colonoscopy Between... | NCT04738578

Studies
A Comparison of Bowel Preparation for Colonoscopy Between Digestive Physicians and Non-digestive Physicians

NCT04738578

Sponsor

Ningbo No. 1 Hospital

Status

Completed

Last Update Posted

Feb 4, 2021Actual

Enrollment

671Actual

Phase

Not provided

Conditions

Bowel Preparation

Interventions

Not provided

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

Dec 2019

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

Dec 1, 2019Actual

Primary Completion Date

Oct 30, 2020Actual

Completion Date

Nov 2, 2020Actual

First Submitted Date

Jan 18, 2021

First Submission Date that Met QC Criteria

Feb 1, 2021

First Posted Date

Feb 4, 2021Actual

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

Feb 1, 2021

Last Update Posted Date

Feb 4, 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

The diagnostic accuracy of colonoscopy depends on the quality of bowel preparation, which is a critical element associated with the diagnostic yield, difficulty, time required, and the completeness of colonoscopy. The non-digestive physicians seemed to have a lower quality of bowel preparation compare to the digestive physicians. Therefore, investigators planned to evaluate the risk factors for suboptimal intestinal preparation in outpatients from the perspective of digestive doctors and non-digestive.

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

Retention

Enrollment

671Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adequate bowel preparation	BBPS score (defined as a BBPS score of 2 or higher in any segment and the total BBPS≥6)	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All outpatients who have already completed the colonoscopy during December 2019 and October 2020.

Exclusion Criteria:

Patients with incomplete critical information, primary outcome, and baseline characteristics missing as well as examinations in hospitalized patients were excluded.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Outpatients 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		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41822094	Derived	Liu C, Yuan X, Gao H, Zhang Z, Wang W, Xie J, Lu H, Chen J, Yu C, Xu L. Real-word evaluation of differences in bowel preparation for colonoscopy between the digestive and the non-digestive physicians: A retrospective study. Front Gastroenterol (Lausanne). 2022 Jul 28;1:946459. doi: 10.3389/fgstr.2022.946459. eCollection 2022.