Clinical trial NCT04193449: Colonoscopy Outcome Database
Official title: Endoscopy Database for Evaluation of Predictors of Colonoscopy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy Procedures
Keywords: colonoscopy
indications
outcome
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2019-12-10
Enrollment: 23000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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.

Primary outcomes:
measure: Number of participants in various predicting factor's groups including sex, age, procedure indication and urgency.
timeFrame: 1/1/2010 to 1/1/2016.
measure: Number of participants in different outcome groups, including normal colonoscopy, presence of pathology, and presence of interventional pathology.
timeFrame: 1/1/2010 to 1/1/2016.
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Pradeep Bhandari, Prof
role: PRINCIPAL_INVESTIGATOR
References: