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Trial registered on ANZCTR


Registration number
ACTRN12618001388202
Ethics application status
Approved
Date submitted
14/08/2018
Date registered
17/08/2018
Date last updated
8/01/2020
Date data sharing statement initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Evening Before Bowel Preparation With Loperamide Versus Split Bowel Preparation in Colonoscopy Patients
Scientific title
Randomised Controlled Trial of Evening Before Bowel Preparation With Loperamide Versus Split Bowel Preparation in Colonoscopy Patients - A Non-inferiority Study
Secondary ID [1] 295804 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy preparation 309239 0
Condition category
Condition code
Oral and Gastrointestinal 308114 308114 0 0
Crohn's disease
Oral and Gastrointestinal 308115 308115 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 308116 308116 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Split Dose Prep (Prep 1):
• 1 Picosalax sachet mixed with 150ml warm water. Administer at 1900hrs day before procedure followed by at least 5 x 250ml drinks of clear liquids spread over several hours
• Bisacodyl tablets 5mg x3 (total 15mg). Administer at 1900hrs day before procedure.
• 1 Picosalax sachet mixed with 150ml warm water. Administer at 0500hrs day before procedure followed by at least 2x250ml drinks of clear liquids until 0600.

Adherence to this process will be monitored with a participant diary which will be reviewed upon arrival for a colonoscopy. This diary will ask patients to document the medication, time and dose taken of the prescribed regime.
Intervention code [1] 312136 0
Treatment: Drugs
Comparator / control treatment
Evening Before Prep with Loperamide (Prep 2):
• 1 Picosalax sachet mixed with 150ml warm water. Administer at 1700 hrs day before procedure followed by at least 5 x 250ml drinks of clear liquids spread over several hours.
• Bisacodyl tablets 5mg x3 (total 15mg). Administer at 1700hrs day before procedure.
• 1 Picosalax sachet mixed with 150ml warm water. Administer at 2200hrs day before procedure followed by at least 2x250ml drinks of clear liquids. Drink clear liquids till 2330hrs.
• Loperamide tablets 2mg x2 (total 4mg). Administer with a sip of water after the 2200 sachet has had sufficient effect on opening patient bowels before patient goes to bed.
• Patients not to ingest clear liquids past 11.30pm

Adherence to this process will be monitored with a participant diary which will be reviewed upon arrival for a colonoscopy. This diary will ask patients to document the medication, time and dose taken of the prescribed regime. They must also document the number of bowel openings (visits to toilet) they had night before they took the loperamide.
Control group
Active

Outcomes
Primary outcome [1] 307091 0
Quality of bowel cleanliness assessed by a single endoscopist using the Ottawa Bowel Preparation Scale
Timepoint [1] 307091 0
Immediate - at time of colonoscopy
Secondary outcome [1] 350661 0
Adenoma detection rate (ADR)
Measured by documenting if patient had one or more adenomas detected and removed - the ADR is the percentage of all participants studied who had one or more adenomas detected and removed.
Timepoint [1] 350661 0
Detection of an adenoma per patient - immediate
Adenoma detection rate - over the duration of the study (12 months)
Secondary outcome [2] 350662 0
Right colon bile staining scores
- as assessed by endoscopist using Caecal Bile Staining Score from:
Keeping the Cecum Clean: A Randomized, Prospective, Placebo-Controlled Trial of Loperamide as Part of Preparation for Colonoscopy - Church J. et al.
Timepoint [2] 350662 0
Immediate - at time of colonoscopy
Secondary outcome [3] 350665 0
Patient reported outcomes on bowel preparation acceptability using self-made Patient Bowel Prep Tolerance Questionnaire
Timepoint [3] 350665 0
The questionnaire will be completed once on the morning of procedure on arrival for colonoscopy (around 0700).
It will take into account the experience of the bowel preparation regime over the last 24 hours.

Eligibility
Key inclusion criteria
Patients referred for colonoscopy on a specific single endoscopist nurse led sedation endoscopy list
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with previous bowel resection.
2. Patients with previous incomplete colonoscopy.
3. Patients requiring extended bowel preparation (history of constipation, previous incomplete prep).
4. Patients requiring inpatient bowel preparation.
5. Patients <18 years old or >75 years old.
6. Patients with a history of hypersensitivity or allergy to Loperamide or Picosalax or Bisacodyl.
7. Patients with active bowel inflammation.
8. Patients pregnant or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1) Sealed opaque envelopes
2) Allocation performed by personnel not directly involved with assessing outcomes in study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/08/2018
Actual
1/11/2018
Date of last participant enrolment
Anticipated
1/07/2020
Actual
Date of last data collection
Anticipated
30/07/2020
Actual
Sample size
Target
180
Accrual to date
90
Final
Recruitment outside Australia
Country [1] 20773 0
New Zealand
State/province [1] 20773 0
North Island

Funding & Sponsors
Funding source category [1] 300400 0
Hospital
Name [1] 300400 0
Gisborne Hospital
Country [1] 300400 0
New Zealand
Primary sponsor type
Individual
Name
Dr Sameer Memon
Address
421 Ormond Road
Gisborne Hospital
Private Bag 7001
Gisborne 4040
Country
New Zealand
Secondary sponsor category [1] 299855 0
Individual
Name [1] 299855 0
Dr Jophia Kommunuri
Address [1] 299855 0
421 Ormond Road
Gisborne Hospital
Private Bag 7001
Gisborne 4040
Country [1] 299855 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301206 0
Health and Disability Ethics Committee - Northern B Health and Disability Ethics Committee
Ethics committee address [1] 301206 0
Street Address:
133 Molesworth Street
Thorndon
Wellington 6011

Postal Address:
Ministry of Health
Health and Disability Ethics Committees
PO BOX 5013
Wellington 6140
Ethics committee country [1] 301206 0
New Zealand
Date submitted for ethics approval [1] 301206 0
Approval date [1] 301206 0
09/07/2018
Ethics approval number [1] 301206 0
18/NTB/78

Summary
Brief summary
The quality of bowel preparation (cleanliness of the colon) is important in determining the effectiveness of colonoscopy. Superior cleansing improves the quality of the colonoscopy. Bowel preparation regimes can be administered as either split dose (where bowel preparation regime is divided between the day before and day of colonoscopy) or evening before with loperamide (whole regime is given the evening before colonoscopy and a drug named loperamide is given to help keep the cleansed bowel clean). This study is aimed at identifying which regime would produce a cleaner bowel for colonoscopy. Split dose bowel preparation is gold standard and used around the world. Loperamide is a drug that has been shown to prevent further movement of bowel contents from the upper bowel into the colon. Hence it is possible the addition of loperamide to an evening before regime (not gold standard) will produce a similar if not better outcome than the gold standard (split dose) regime.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86218 0
Dr Sameer Memon
Address 86218 0
421 Ormond Road
Gisborne Hospital
Private bag 7001
Gisborne 4040
Country 86218 0
New Zealand
Phone 86218 0
+64 27 311 5371
Fax 86218 0
Email 86218 0
[email protected]
Contact person for public queries
Name 86219 0
Sameer Memon
Address 86219 0
421 Ormond Road
Gisborne Hospital
Private bag 7001
Gisborne 4040
Country 86219 0
New Zealand
Phone 86219 0
+64 27 311 5371
Fax 86219 0
Email 86219 0
[email protected]
Contact person for scientific queries
Name 86220 0
Sameer Memon
Address 86220 0
421 Ormond Road
Gisborne Hospital
Private bag 7001
Gisborne 4040
Country 86220 0
New Zealand
Phone 86220 0
+64 27 311 5371
Fax 86220 0
Email 86220 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6317Study protocol  [email protected]
6318Informed consent form  [email protected]
6319Ethical approval  [email protected]



Results publications and other study-related documents

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