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Trial registered on ANZCTR


Registration number
ACTRN12613000917730
Ethics application status
Not yet submitted
Date submitted
29/07/2013
Date registered
20/08/2013
Date last updated
15/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Oral Rehydration Solution Orange vs. Apple/Blackcurrant in addition to standard bowel preparation in colonoscopy: a Pilot Study
Scientific title
Oral Rehydration Solution Orange vs. Apple/Blackcurrant in addition to standard bowel preparation in patients undergoing colonoscopy at The Alfred Hospital. Are endoscopists able to predict the colour of OHS ingested in the pre-colonoscopy preparation?
Secondary ID [1] 282916 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel preparation pre-colonoscopy 289729 0
Condition category
Condition code
Oral and Gastrointestinal 290057 290057 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral rehydration solution administered to patients undertaking bowel preparation before colonoscopy procedure.
The oral rehydration solution proposed to be used for this study is HYDRAlyte.
The bowel preparation to be used will be PrepKit C which includes Picoprep (Sodium picosulfate,Magnesium, Citric acid powder for oral solution) and Glycoprep (Sodium chloride, Sodium bicarbonate, Potassium chloride, Macrogol 3350, Sodium sulfate powder for oral solution)


The amount and duration for Group B is as follows.
Day before procedure:
- 5pm : 1st sachet of picoprep with 250ml water + 200ml of HYDRAlyte (Orange)
- 6pm: one sachet of glycoprep mixed with 1L water + 200ml HYDRAlyte (Orange)
- 8pm: 200ml of HYDRAlyte (Orange) +/- extra colourless fluids
- 9pm: 200ml of HYDRAlyte (Orange) +/- extra colourless fluids
- 10pm: 200ml of HYDRAlyte (Orange) +/- extra colourless fluids
Day of procedure:
- 6am : 2nd sachet of picoprep with 200ml of HYDRAlyte (Orange)
- 7am: 200ml of HYDRAlyte (Orange) +/- extra colourless fluids
- 8am: 200ml of HYDRAlyte (Orange) +/- extra colourless fluids
- 9am: 200ml of HYDRAlyte (Orange) with no additional fluids
- 10am: 200ml of HYDRAlyte (Orange) with no additional fluids

The amount and duration for Group C is as follows.
Day before procedure:
- 5pm : 1st sachet of picoprep with 250ml water + 200ml of HYDRAlyte (Apple/Blackcurrant)
- 6pm: one sachet of glycoprep mixed with 1L water + 200ml HYDRAlyte (Apple/Blackcurrant)
- 8pm: 200ml of HYDRAlyte (Apple/Blackcurrant) +/- extra colourless fluids
- 9pm: 200ml of HYDRAlyte (Apple/Blackcurrant) +/- extra colourless fluids
- 10pm: 200ml of HYDRAlyte (Apple/Blackcurrant) +/- extra colourless fluids
Day of procedure:
- 6am : 2nd sachet of picoprep with 200ml of HYDRAlyte (Apple/Blackcurrant)
- 7am: 200ml of HYDRAlyte (Apple/Blackcurrant) +/- extra colourless fluids
- 8am: 200ml of HYDRAlyte (Apple/Blackcurrant) +/- extra colourless fluids
- 9am: 200ml of HYDRAlyte (Apple/Blackcurrant) with no additional fluids
- 10am: 200ml of HYDRAlyte (Apple/Blackcurrant) with no additional fluids


Patients will administer the HYDRAlyte at home using a measuring cup provided by the researchers. As they ingest the fluid they will be asked to tick off or make comment on how much and when they ingested the fluid on a 'Fluid Intake Diary' provided by the researchers.

The adherence to the preparation regimen will be assessed by the researchers primarily by reviewing the above mentioned 'Fluid Intake Diary'.

Active ingredients of HYDRAlyte:

Per sachet: glucose 2.91 g, citric acid 0.88 g, K citrate 0.44 g, NaCl 0.53 g (equiv. glucose 80 mmol/L, citrate 30 mmol/L, K 20 mmol/L, Na 45 mmol/L, Cl 45 mmol/L); sucralose; orange or apple/ blackcurrant flavour
Intervention code [1] 287610 0
Other interventions
Comparator / control treatment
The control group is Group A. Clear fluids administered to patients undertaking bowel preparation before colonoscopy procedure. The clear and colourless fluids that patients are instructed to ingest are; water; soft drinks (lemonade, soda water, clear mineral water); clear fruit flavoured cordials.

The bowel preparation to be used will be PrepKit C which includes Picoprep (Sodium picosulfate,Magnesium, Citric acid powder for oral solution) and Glycoprep (Sodium chloride, Sodium bicarbonate, Potassium chloride, Macrogol 3350, Sodium sulfate powder for oral solution)


The amount and duration for Group A is as follows.
Day before procedure:
- 5pm : 1st sachet of picoprep with 250ml water + 200ml of water
- 6pm: one sachet of glycoprep mixed with 1L water + 200ml water
- 8pm: 200ml of water +/- extra colourless fluids
- 9pm: 200ml of water +/- extra colourless fluids
- 10pm: 200ml of water +/- extra colourless fluids
Day of procedure:
- 6am : 2nd sachet of picoprep with 200ml of water
- 7am: 200ml of water +/- extra colourless fluids
- 8am: 200ml of water +/- extra colourless fluids
- 9am: 200ml of water with no additional fluids
- 10am: 200ml of water with no additional fluids

Patients will administer the water at home using a measuring cup provided by the researchers. As they ingest the fluid they will be asked to tick off or make comment on how much and when they ingested the fluid on a 'Fluid Intake Diary' provided by the researchers.

The adherence to the preparation regimen will be assessed by the researchers primarily by reviewing the above mentioned 'Fluid Intake Diary'.
Control group
Active

Outcomes
Primary outcome [1] 290108 0
Percentage of correct estimations of colour of oral hydration solution consumed before colonoscopy will be the primary endpoint. This will inform future studies and suitability of use of these products pre-procedure.

The endoscopist will be asked to assess the acceptability of the bowel preparation at completion of the colonoscopy on the day of procedure. They will rate the bowel preparation using the Ottawa Scale, and will complete a datasheet where they will be asked to estimate which colour fluid the patient ingest pre-procedure.
Timepoint [1] 290108 0
Day of procedure
Secondary outcome [1] 303963 0
Whether the use of oral hydration solutions can reduce the effects of dehydration pre-colonoscopy. And increase tolerability of bowel preparation.

Patients will be asked to fill in a questionnaire on completion of their bowel preparation before colonoscopy. At this time they will be asked about their experience of the bowel preparation regimen and symptoms experienced. For example whether they experienced nausea, vomitting, headache, abdominal cramping etc. They will also be asked whether they would repeat the regimen if they were to have another colonoscopy. This questionnaire has been developed specifically for this study and incorporates a numerical scale from Best to Worst outcome.
Timepoint [1] 303963 0
Day of procedure (before anaesthetic, whilst waiting for their colonoscopy)
Secondary outcome [2] 304184 0
The researchers will also investigate whether the inclusion of an OHS has an impact on bowel cleanliness. The endoscopist will complete a datasheet with a bowel cleansing scale to answer this question.
Timepoint [2] 304184 0
Day of procedure
Secondary outcome [3] 304204 0
Polyp/adenoma detection assessed. The endoscopist will complete a datasheet to answer this question.
Timepoint [3] 304204 0
Day of procedure
Secondary outcome [4] 304205 0
The caecal/terminal ileal intubation rate. The endoscopist will complete a datasheet to answer this question.
Timepoint [4] 304205 0
Day of procedure
Secondary outcome [5] 304206 0
Time taken to complete the colonoscopy. The endoscopist will complete a datasheet to answer this question.
Timepoint [5] 304206 0
Day of procedure

Eligibility
Key inclusion criteria
Consenting adult patients (aged >18 years) undergoing outpatient colonoscopy for clinically accepted indications. Clinically accepted indications for colonoscopy generally include but are not restricted to; iron deficiency anaemia, surveillance of bowel polyps, colorectal cancer screening, assessment of symptoms such as abdominal pain, diarrhoea and constipation, assessment or investigation of inflammatory bowel disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are conditions generally considered as exclusions to colonoscopy in normal clinical practice. They are suspected bowel perforation, gastric outlet obstruction, toxic megacolon, severe colitis, and pregnancy or lactation. For additional safety, will also exclude patients with the relative contraindications of renal impairment (eGFR<60) and heart failure (New York Heart Association Class III or IV). Prep-Kit C is contraindicated in individuals with phenylketonuria, due to the presence of aspartame and patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency given it contains ascorbic acid (vitamin C) which is an oxidant. Diabetics will also be excluded due to the high level of dextrose in OHS. Any person with a known hypersensitivity to a constituent of Picoprep, Glycoprep or OHS will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants will be undergoing colonoscopy at the Alfred for clinically accepted indications. Patients will be recruited and written informed consent will be acquired before enrolling patients into the study.
All patients enrolled in the study will use our current standard bowel preparation of Prep-Kit C (2 sachets of Picoprep and 1 sachet of Glycoprep). Consenting patients will be recruited from the afternoon colonoscopy booking list prior to randomisation. Patients will be randomly allocated to one of three groups. Group A will be the control group ie; standard bowel preparation with no oral hydration solution. In order for the groups to have consistent amounts of fluid and therefore be comparable; Group A will be instructed to have a minimum of 2 litres of fluid during their bowel preparation. Group B will have 2 litres of orange colour OHS during their bowel preparation pre-colonoscopy. And Group C will have 2 litres of Apple/Blackcurrant purple coloured OHS preparation.

Allocation will be via sealed opaque envelopes that are mailed to patients by the endoscopy bookings nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A sealed envelope with instructions, Prep-Kit, OHS product (if randomised to Group B or C) and measuring instrument will be mailed along with other standard instructions about the time of their procedure. The bookings clerk will record the patient’s hospital ‘UR’ number with their study reference number on a password protected database at the time of randomisation.

The radomised study numbers are created via a randomisation table provided by statisticians via a computerised sequence generation.
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287693 0
Commercial sector/Industry
Name [1] 287693 0
Hydration Pharmaceuticals Trust
Country [1] 287693 0
Australia
Primary sponsor type
Individual
Name
Assoc/Prof Gregor Brown
Address
PO Box 315, The Alfred, Prahran, VIC, Australia 3181
Country
Australia
Secondary sponsor category [1] 286426 0
None
Name [1] 286426 0
Address [1] 286426 0
Country [1] 286426 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289653 0
The Alfred Hospital Human Research and Ethics Committee
Ethics committee address [1] 289653 0
Ethics committee country [1] 289653 0
Australia
Date submitted for ethics approval [1] 289653 0
31/07/2013
Approval date [1] 289653 0
Ethics approval number [1] 289653 0

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

Contacts
Principal investigator
Name 41798 0
A/Prof Gregor Brown
Address 41798 0
Department of Gastroenterology - 4th floor
The Alfred
PO BOX 315
Prahran, VIC 3181
Country 41798 0
Australia
Phone 41798 0
+61 03 9076 3325
Fax 41798 0
+61 03 9076 2194
Email 41798 0
g.brown@alfred.org.au
Contact person for public queries
Name 41799 0
Jonathan Tan
Address 41799 0
Department of Gastroenterology - 4th floor
The Alfred
PO BOX 315
Prahran, VIC 3181
Country 41799 0
Australia
Phone 41799 0
+61 03 9076 3325
Fax 41799 0
+61 3 9076 2194
Email 41799 0
Jonathan.TAN@alfred.org.au
Contact person for scientific queries
Name 41800 0
Jonathan Tan
Address 41800 0
Department of Gastroenterology - 4th floor
The Alfred
PO BOX 315
Prahran, VIC 3181
Country 41800 0
Australia
Phone 41800 0
+61 03 9076 3325
Fax 41800 0
Email 41800 0
Jonathan.TAN@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.