None listed
Conditions
Brief summary
This trial aims to determine whether the efficacy of standard bowel preparation for colonoscopy can be improved by the addition of an osmotic laxative, Movicol. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been referred for an outpatient colonoscopy procedure. Study details: All participants in this trial will be randomly allocated (by chance) to either the Movicol group or the standard care group. Participants in the Movicol group will receive 8 sachets of Movicol to be mixed with water and consumed once/twice per day (according to a strict schedule) in the 5 days leading up to the colonoscopy procedure. On the morning of the procedure, these participants will also consume one preparation of the standard care Prepkit C. Participants in the standard care group will be given the usual care low residue White Diet (for 2 days prior to the day of the procedure ) and Prepkit C (consisting of a first sachet of PICO PREP and one sachet of GLYCOPREP taken the day before the procedure, and a second sachet of PICO PREP the morning of the day of procedure. Participants will be asked to complete a form indicating when each dose was taken, and will be asked to complete a questionnaire on arrival at hospital for the procedure. The doctor performing the procedure will be asked to rate the quality of the bowel preparation. It is hoped that this trial will provide information on the efficacy of Movicol as an addition to standard care preparation for colonoscopy.
Interventions
Consenting patients who are to undergo routine colonoscopy will be randomised to receive the standard bowel preparation or Movicol (intervention) in addition to the standard bowel preparation.
Movicol is a combination product available in powder form. Each sachet of Movicol powder contains Macrogol-3350 13.125 g, Sodium chloride 350.7 mg, Sodium bicarbonate 178.5 mg, Potassium chloride 46.6 mg Lemon flavor and Potassium acesulfame as a sweetener.
Macrogol 3350 exerts an osmotic action in the g
Consenting patients who are to undergo routine colonoscopy will be randomised to receive the standard bowel preparation or Movicol (intervention) in addition to the standard bowel preparation. Movicol is a combination product available in powder form. Each sachet of Movicol powder contains Macrogol-3350 13.125 g, Sodium chloride 350.7 mg, Sodium bicarbonate 178.5 mg, Potassium chloride 46.6 mg Lemon flavor and Potassium acesulfame as a sweetener. Macrogol 3350 exerts an osmotic action in the gut, which induces a laxative effect. Movicol is routinely used as laxative by increasing stool volume and is indicated in the treatment of chronic constipation. Movicol is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of abdomen and rectum. Each Movicol sachet should be dissolved in 125ml water and taken orally. The usual adult dosage is 1 sachet daily. This may be increased to 2-3 sachets daily as required. Participants in the intervention arm will receive 8 sachets of Movicol to be taken over the 5 days prior to the day of the procedure. The first sachet is to be taken in the evening 5 days prior to the procedure. One sachet is taken at 7am and 7pm for the next 4 days. The eighth sachet is taken on the morning of the day prior to the procedure, ahead of commencing the standard bowel preparation of Prepkit C. An instruction sheet and schedule for taking the Movicol sachets will be provided with the sachets. Participants will be asked to tick a box against each dose taken and return the form on the day of the procedure. This will enable researchers to monitor compliance with the intervention.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Consenting adult patients referred for outpatient colonoscopy procedure for clinically accepted indications (these 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 as follows: Conditions which are exclusions to colonoscopy in normal clinical practice (suspected bowel perforation, gastric outlet obstruction, toxic megacolon, severer colitis, pregnancy or lactation) Significant renal failure (eGFR<30) Significant heart failure (New York Heart Association Class III or IV) Type 1 diabetes Cystic fibrosis Phenylketonuria (Prepkit C contraindicated) Known hypersensitivity to a constituent of Picoprep, Glycoprep or Picosalax and Movicol (Type 1 diabetics or Cystic Fibrosis patients are excluded as they follow specific guidelines for bowel preparation for colonoscopy at Alfred Hospital.)
Outcome results
None listed