None listed
Conditions
Brief summary
This pilot study wishes to investigate whether the consumption of an oral hydration solution (OHS) during bowel preparation will affect the faecal effluent in terms of colour or quality. The investigators will examine whether the endoscopist can detect which colour OHS has been used in conjunction with bowel preparation (if any), and whether the use of an OHS in conjunction with current bowel preparations pre-colonoscopy can reduce the effects of dehydration (ie nausea, dry mouth, headache, lethargy, increased thirst). This may aid in the tolerability of bowel preparation, which in turn may result in better compliance with bowel preparation, with adequate fluid consumption being achieved. The researchers will also investigate whether the inclusion of an OHS has an impact on bowel cleanliness, polyp/adenoma detection, caecal/terminal ileal intubation rate, and time taken to complete the colonoscopy.
Interventions
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
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
Sponsors
Assoc/Prof Gregor Brown
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed