Skip to content

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000747729
Acronym
DIGICLEAN (DIGItising CoLonoscopy care pathways to Enhance bowel preparation And polyp detectioN)
Enrollment
0
Registered
2022-05-25
Start date
2023-03-31
Completion date
2024-09-30
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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 ‘Standard Bowel Preparation’ 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.

Interventions

Participants in the interventional arm of the study will receive their bowel preparation instructions delivered via scheduled SMS, web-based smartphone application, email, and videos. All enrolled participants must possess a smartphone device. The interventional arm will occur in parallel design with the control arm. Depending on whether participants have a history of constipation, bloating, or diverticular disease as assessed by the faecal occult blood test (FOBT) nurse or the gastroenterologis

Participants in the interventional arm of the study will receive their bowel preparation instructions delivered via scheduled SMS, web-based smartphone application, email, and videos. All enrolled participants must possess a smartphone device. The interventional arm will occur in parallel design with the control arm. Depending on whether participants have a history of constipation, bloating, or diverticular disease as assessed by the faecal occult blood test (FOBT) nurse or the gastroenterologist at the initial phone call, participants will be stratified into one of two groups depending on their indicated bowel preparation regimens. Participants will be either given Standard Bowel Preparation instructions with PLENVU [macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride, potassium chloride; polyethylene glycol containing ascorbic acid (PEG-ASC)], or Enhanced Bowel Preparation [PLENVU plus daily Movicol (sodium chloride, potassium chloride, bicarbonate, macrogol 3350) and Senokot (sennoside)]. Additional aperients, such as Movicol and Senokot, will be encouraged in the interventional arm through dynamic multimedia instructions if indicated. Participants will be asked to take PLENVU over a two-day split dosing schedule with the first 500 mL dose of PLENVU (including additional 500 mL of clear fluid) taken in the evening before the clinical procedure (at 6 pm) and the second 500 mL dose (including additional 500 mL of clear fluid) in the early morning of the day of the clinical procedure (at 5 am for morning procedure or 8 am for afternoon procedures). Participants in the Enhanced Bowel Preparation group will also take 1 sachet of Movicol and 2 Senokot tablets daily at 0800 in the week leading up to the colonoscopy. In the week leading up to the colonoscopy, depending on the bowel preparation group, regular SMS will be sent to the participant one to three times daily to remind participants regarding appropriate dietary and bowel preparation instructions (at 0800, 1700 and 2000). Scheduled SMS and messaging will also occur on the day prior to colonoscopy occurring at indicated times to consume bowel preparation. Daily assessment of dietary adherence and constipation, which involves completing a survey lasting for two to five minutes, will occur via the web-based smartphone application and depending on patient reported responses, dietary advice or alterations in bowel preparation will be given. The message delivery system will be monitored via a web interface by the FOBT nurse or the study nurse. A video explaining the procedure and the bowel preparation course will be sent to the participant via SMS and email at the time of enrolment and at 7 days before the colonoscopy, which can be re-accessed through a hyperlink. Participants will be asked to self-report their stool consistency and stool colour via the smartphone app after completion of their bowel preparation before the colonoscopy, and if unsatisfactory, may be advised to request a Fleet enema (sodium biphosphate and sodium phosphate) at time of arrival to the hospital. A Fleet enema is a laxative given via the rectum which causes bowel movements in around give minutes. After the colonoscopy, patient reported measures will be assessed. Additionally, depending on the site of the study, some participants will undergo their pre-anaesthetic assessment using the web-based application which will occur once at the time of enrolment.

Sponsors

Dr Viraj Kariyawasam
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Indicated for colonoscopy as an outpatient with a positive faecal occult blood test, rectal bleeding, or iron deficiency anaemia 2. Aged 45 years and above 3. Have a smartphone device which can support web browsing and use the web-based application 4. Be able to independently give informed consent by verbal means 5. Possess a working email address for the purposes of consenting and information sharing

Exclusion criteria

1. Non-English-speaking backgrounds 2. Inpatient at any hospital 3. Scheduled colonoscopy date changed or delayed due to provider factors affecting the normal care sequence 4. Colonoscopy within the last 5 years. 5. Previous bowel resection or stoma 6. Glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbic acid in PEG-ASC) 7. New York Heart Association heart failure classes III or IV 8. Chronic kidney disease stages 4 and 5 (eGFR < 30 mL/min/1.73m2) 9. Not indicated or contraindicated for a colonoscopy 10. Contraindication to standard bowel preparation regimens 11. Hypersensitivity to any ingredient in PLENVU 12. Cognitive disorder which would normally preclude from independent standard bowel preparation 13. Inflammatory bowel disease 14. Known polyp or diagnosis of colorectal cancer

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026