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Digitising colonoscopy care pathways and enhancing bowel preparation quality with patient reported measures (DIGICLEAN). - Trial ANZCTR12622000747729

Access comprehensive clinical trial information for ANZCTR12622000747729 through Pure Global AI's free database. This Not Applicable trial is sponsored by Dr Viraj Kariyawasam and is currently Not yet recruiting. The study focuses on colorectal cancer.

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ANZCTR12622000747729
Not Applicable
Not yet recruiting
diagnostic test
Trial Details
Australian New Zealand Clinical Trials Registry โ€ข ANZCTR12622000747729
Pure Global
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Digitising colonoscopy care pathways and enhancing bowel preparation quality with patient reported measures (DIGICLEAN).
A multicentre, colonoscopist-blinded, randomised controlled trial to determine the efficacy of dynamic multimedia bowel preparation instructions versus standard instructions as control on adenoma detection and patient reported measures in adults aged 45 years and older indicated for a colonoscopy.

Study Focus

colorectal cancer

Interventional

diagnostic test

Sponsor & Location

Dr Viraj Kariyawasam

Western Sydney Local Health District, Westmead Hospital, Research Education Network;; Norgine Pty Limited

Australia

Timeline & Enrollment

Not Applicable

Mar 31, 2023

Sep 30, 2024

Primary Outcome

Comparison of the adenoma detection rate based on histopathology assessment of biopsy samples collected at the time of colonoscopy in patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive verbal and/or written bowel preparation instructions.;; Compare the patient reported measures using the validated colonoscopy-specific Newcastle ENDOPREM Questionnaire on the day after colonoscopy between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.

Summary

This study aims to determine whether delivery of bowel preparation instructions for a colonoscopy through dynamic multimedia instructions (scheduled SMS, smartphone application, video instructions, and email) has an impact on the quality of bowel preparation, diagnosis rate and colonoscopy procedure times compared to instructions that are given verbally, in hard copy or via email only. Who is it for? You may be eligible for this study if you are aged 45 years or older, you have been scheduled to attend a colonoscopy as an outpatient to screen for potential colorectal cancer and you have access to a smartphone. Study details All participants will be instructed to take either a โ€˜Standard Bowel Preparationโ€™ or 'Enhanced Bowel Preparation' depending upon their bowel habits. The only difference between the groups is how the instructions for bowel preparation will be delivered. All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive their bowel preparation instructions either by SMS, video and through a smartphone app, or to receive their instructions verbally, in paper/hard copy format or email only. Participants who are allocated to the SMS/smartphone group will receive 1-3 daily reminders throughout the week prior to their colonoscopy and will be asked to enter details about their preparation each day for 1 week prior to the colonoscopy. This should only take 2-5 minutes per day. Participants who are allocated to the paper/email group will receive a copy of the instructions once only and will not receive any reminders prior to their colonoscopy. All participants will be asked to complete a series of questionnaires after their colonoscopy, this is anticipated to take 10 minutes. It is hoped this research will demonstrate whether a more interactive delivery of instructions for colonoscopy has any impact upon the ability to diagnose bowel cancer and the ease of the procedure itself. If this method is successful, it may be implemented on a larger scale which could improve the diagnosis and treatment of bowel cancers.

ICD-10 Classifications

Malignant neoplasm of colon
Malignant neoplasm: Descending colon
Malignant neoplasm: Colon, unspecified
Malignant neoplasm: Ascending colon
Malignant neoplasm: Overlapping lesion of colon

Data Source

Australian New Zealand Clinical Trials Registry

ANZCTR12622000747729

Non-Device Trial