Oral Rehydration Solution Orange vs. Apple/Blackcurrant in addition to standard bowel preparation in colonoscopy: a Pilot Study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2013
INTERVENTION: 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 CONDITION: Bowel preparation pre‐colonoscopy PRIMARY OUTCOME: 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. SECONDARY OUTCOME: Polyp/adenoma detection assessed. The endoscopist will complete a datasheet to answer this question. The caecal/terminal ileal intubation rate. The endoscopist will complete a datasheet to answer this question. 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. Time taken to complete the colonoscopy. The endoscopist will complete a datasheet to answer this question. 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. 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.
Epistemonikos ID: 8f36a96894bd9e807ba2d8b5ec6bbb1a844a40a2
First added on: Aug 25, 2024