Endoscopy Quality Study

Assessing the Quality of Upper Gastrointestinal Endoscopy - Factors That Affect it and Validation of a Bespoke Mucosal Visual Scale

This study seeks to establish factors that influence the view at endoscopy. To achieve this patients, who have been already booked for endoscopy, will complete a questionnaire prior to their procedure. Demographic and endoscopist factors will also be ascertained.

The view at endoscopy will then be reviewed and scored against a rating scale, which will be validated as a first phase of the study. Factors can then be sought that are associated with a good endoscopic view.

Study Overview

• Status: Unknown
• Conditions: Endoscopy
• Intervention / Treatment: Other: Questionniare only

• Study Type: Observational
• Enrollment (Anticipated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for upper GI endoscopy (OGD)

Description

Inclusion Criteria:

• Any patient booked for routine OGD

Exclusion Criteria:

• Inpatient endoscopy
• Barretts surveillance endoscopy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All included participants; Patients that complete study questionnaire and have endoscopy recorded.	Other: Questionniare only; A pre-procedure questionnaire will be completed by all participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
View seen at endoscopy	This is the quality of view seen at endoscopy based upon a bespoke scale	Endoscopy will be performed as booked for standard care. This will be the same day as consent.

Collaborators and Investigators

• Sponsor: Sandwell & West Birmingham Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 15GAST29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No