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Trial registered on ANZCTR


Registration number
ACTRN12622000747729
Ethics application status
Approved
Date submitted
17/05/2022
Date registered
25/05/2022
Date last updated
23/02/2024
Date data sharing statement initially provided
25/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Digitising colonoscopy care pathways and enhancing bowel preparation quality with patient reported measures (DIGICLEAN).
Scientific title
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.
Secondary ID [1] 307118 0
None
Universal Trial Number (UTN)
U1111-1278-2201
Trial acronym
DIGICLEAN (DIGItising CoLonoscopy care pathways to Enhance bowel preparation And polyp detectioN)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer 326283 0
Condition category
Condition code
Cancer 323597 323597 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323578 0
Early detection / Screening
Intervention code [2] 323630 0
Diagnosis / Prognosis
Comparator / control treatment
Participants in the control arm of the study will receive their bowel preparation instructions delivered via routine standard means, such as written, verbal, emailed or posted instructions. Depending on whether participants have a history of constipation, bloating, or diverticular disease as assessed by the 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 instructions for Standard Bowel Preparation 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 regular Movicol (sodium chloride, potassium chloride, bicarbonate, macrogol 3350) and Senokot (sennosides)]. Additional aperients may be encouraged in the control arm but this will be presented as paper-based/written instructions. The bowel preparation regimens are the same as the interventional groups. Participants in the control arm will be given the same instructions in paper-based/emailed form (including instructions for additional aperients), but not through dynamic multimedia messaging and participants will not be routinely assessed for constipation leading up to their procedure. Participants will be advised via written means to request a Fleet enema (sodium biphosphate and sodium phosphate) at time of arrival to the hospital if their stool consistency or stool colour is unsatisfactory. A Fleet enema is a laxative given via the rectum which causes bowel movements in around give minutes. After the colonoscopy, patient reported measures and self-reported adherence will be assessed. Adherence to diet, constipation, and bowel preparation routine will not be assessed prior to colonoscopy via digital means.
Control group
Active

Outcomes
Primary outcome [1] 331377 0
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.
Timepoint [1] 331377 0
At the time of colonoscopy assessment.
Primary outcome [2] 331379 0
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.
Timepoint [2] 331379 0
One day after colonoscopy assessment.
Secondary outcome [1] 409661 0
Compare the Boston Bowel Preparation Score 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.
Timepoint [1] 409661 0
At the time of colonoscopy assessment.
Secondary outcome [2] 409662 0
Compare the caecal intubation success rate at the time of colonoscopy on review of the procedural report between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.
Timepoint [2] 409662 0
At the time of colonoscopy assessment.
Secondary outcome [3] 409663 0
Compare the mean procedural time duration measured in minutes from the time of colonoscope insertion through to removal from the anal canal on review of the procedural report between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.
Timepoint [3] 409663 0
At the time of colonoscopy assessment.
Secondary outcome [4] 409664 0
Compare the cancellation and non-presentation rate related to patient factors on review of medical records between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.
Timepoint [4] 409664 0
At the time of colonoscopy assessment.

Eligibility
Key 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
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque, sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Participants will be stratified by their indicated bowel preparation regimen: PLENVU only or Enhanced Bowel Preparation in patients with a history of constipation, diverticular disease, or bloating.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations were based on a previous randomised controlled trial by Walter, Frank et al., which compared the quality of bowel preparation and adenoma detection rates with 2 L polyethylene glycol (PEG) plus ascorbic acid, in patients who received a smartphone application versus patients who received written materials that had the same contents.

This study is of independent cases and controls with 1 control per case. Prior data from Walter, Frank et al. indicate that the adenoma detection rate among controls is 0.27. If the true adenoma detection rate for experimental subjects is 0.35, the study will need 524 experimental subjects and 524 control subjects to be able to reject the null hypothesis that the adenoma detection rates for experimental and control subjects are equal with probability (power) 0.80. The Type I error probability associated with this test of this null hypothesis is 0.05. An uncorrected chi-squared statistic to evaluate this null hypothesis will be used.

Given the multiple stages of data collection in the interventional arm (at 1 week prior, -3 days prior, -1 day prior and morning of procedure) which may be burdensome as well as some patients who may not show up for the procedure, a drop-out rate of 10% will be anticipated. The adjusted sample size reflecting this is 1294. To account for these factors, we will aim to enrol 647 participants in both the interventional and control arms.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
1294
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22369 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 22370 0
Mount Druitt Hospital - Mount Druitt
Recruitment hospital [3] 22371 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 22372 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 37532 0
2148 - Blacktown
Recruitment postcode(s) [2] 37533 0
2770 - Mount Druitt
Recruitment postcode(s) [3] 37534 0
2139 - Concord
Recruitment postcode(s) [4] 37535 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 311426 0
Hospital
Name [1] 311426 0
Western Sydney Local Health District, Westmead Hospital, Research Education Network
Country [1] 311426 0
Australia
Funding source category [2] 313278 0
Commercial sector/Industry
Name [2] 313278 0
Norgine Pty Limited
Country [2] 313278 0
Australia
Primary sponsor type
Individual
Name
Dr Viraj Kariyawasam
Address
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148
Country
Australia
Secondary sponsor category [1] 312820 0
Individual
Name [1] 312820 0
Dr Michael Au
Address [1] 312820 0
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148
Country [1] 312820 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310903 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 310903 0
Ethics committee country [1] 310903 0
Australia
Date submitted for ethics approval [1] 310903 0
15/01/2022
Approval date [1] 310903 0
21/03/2022
Ethics approval number [1] 310903 0
2022/ETH00059

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119290 0
Dr Viraj Kariyawasam
Address 119290 0
Department of Gastroenterology and Hepatology
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148
Country 119290 0
Australia
Phone 119290 0
+61 493 267 442
Fax 119290 0
Email 119290 0
[email protected]
Contact person for public queries
Name 119291 0
Michael Au
Address 119291 0
Department of Gastroenterology and Hepatology
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148
Country 119291 0
Australia
Phone 119291 0
+61 494 042 862
Fax 119291 0
Email 119291 0
[email protected]
Contact person for scientific queries
Name 119292 0
Michael Au
Address 119292 0
Department of Gastroenterology and Hepatology
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148
Country 119292 0
Australia
Phone 119292 0
+61 494 042 862
Fax 119292 0
Email 119292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved by Human Research Ethics Committee at the present time.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16077Ethical approval  [email protected]
16078Informed consent formhttps://bmjopen.bmj.com/content/13/7/e073843 [email protected]
16079Study protocolhttps://bmjopen.bmj.com/content/13/7/e073843 [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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