Colonoscopy Outcome Database | NCT04193449

Studies
Colonoscopy Outcome Database

NCT04193449

Sponsor

Portsmouth Hospitals NHS Trust

Status

Completed

Last Update Posted

Apr 7, 2023Actual

Enrollment

23,000Actual

Phase

Not provided

Conditions

Colonoscopy Procedures

Interventions

colonoscopy

Countries

United Kingdom

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

Apr 2023

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, 2018Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jan 1, 2020Actual

First Submitted Date

Dec 3, 2019

First Submission Date that Met QC Criteria

Dec 6, 2019

First Posted Date

Dec 10, 2019Actual

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

Apr 6, 2023

Last Update Posted Date

Apr 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of this database is to keep routinely collected endoscopic data and outcomes in a single database which will enable the gastroenterology team to perform analyses to improve services and patient outcomes.

Detailed Description

Colonoscopy is an invasive procedure that is currently performed for a variety of reasons that centre on the detection and treatment of bowel disorders. It is time-consuming and an expensive process to develop a skilled workforce that has both the skills and the resources to provide a satisfactory colonoscopy service to the general population. Colonoscopy is also an invasive procedure associated with some serious complications like bleeding and perforation. Endoscopy resources are limited by theater space, number of endoscopes and skilled workforce. With the introduction of bowel cancer screening programmes, colonoscopy capacity has been stretched to the limit, such that extremely long waiting lists are an increasingly growing problem.

The rationale for having the database in Portsmouth is because it is a large referral centre and already has an electronic hospital endoscopy reporting system. All useful information is already stored on this platform, but the relevant clinical information is not easy to analyse in the current format. Therefore, we plan to export relevant clinical information to a database to permit retrospective data analysis. There is no need to collect any prospective data as we can achieve the desired outcomes with the current information.The research database will facilitate definitions of clinical pathways to reduce the present burden of colonoscopy on the health care system.

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

23,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult patients undergoing colonoscopy		All patients' ≥18 years of age who underwent endoscopy at Portsmouth Hospitals NHS Trust, including repeat colonoscopies performed for surveillance purposes aged ≥18 in either males or females.	Diagnostic Test: colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
colonoscopy	Diagnostic Test	colonoscopy procedure	Adult patients undergoing colonoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants in various predicting factor's groups including sex, age, procedure indication and urgency.		1/1/2010 to 1/1/2016.
Number of participants in different outcome groups, including normal colonoscopy, presence of pathology, and presence of interventional pathology.		1/1/2010 to 1/1/2016.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients' ≥18 years of age who underwent endoscopy at Portsmouth Hospitals NHS Trust, including repeat colonoscopies performed for surveillance purposes aged ≥18 in either males or females

Exclusion Criteria:

Patients under 18 years age.

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

All patients' ≥18 years of age who underwent endoscopy at Portsmouth Hospitals NHS Trust, including repeat colonoscopies performed for surveillance purposes aged ≥18 in either males or females

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pradeep Bhandari, Prof	Portsmouth Hospitals NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Portsmouth Hospitals NHS Trust		Portsmouth	Hampshire	PO6 3LY	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003113	Colonoscopy

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

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Browse Branches

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