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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04193449
Other study ID # PHT/2019/09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date January 1, 2020

Study information

Verified date April 2023
Source Portsmouth Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23000
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
colonoscopy
colonoscopy procedure

Locations

Country Name City State
United Kingdom Portsmouth Hospitals NHS Trust Portsmouth Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants in various predicting factor's groups including sex, age, procedure indication and urgency. 1/1/2010 to 1/1/2016.
Primary 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.